Clinical Trials Search
A Phase II Trial of Subcutaneous Recombinant Human Interleukin-11 (rhlL-11) with Subcutaneous Recombinant Human Granulocyte Macrophage-colony Stimulating Factor (rhGM-CSF, Leukine) in Patients < 56 years of age with Acute Myeloid Leukemia (AML) Receiving High-Dose Cytarabine During Induction and Consolidation Chemotherapy
E3997
- Eligibility:Click Here to View1.0) =18 and = 56yrs
2.0) No previous Chemo for AML (hydroxyurea OK)
3.0) PS 0-1 - Consent forms:You must be logged in to view the documents.
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Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
E3A06
- Eligibility:Click Here to View
*Training required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
SJMH, St. Alphonsus, Genesys, Allegiance, Oakwood, St. John, Macomb, Oakland, Livonia, Saginaw, Lehigh-Diagnosis of asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 mo meeting both of the following criteria:
--Bone marrow plasmacytosis with greater than or equal to 10% plasma cells or sheet of plasma cells by bone marrow aspiration and/or biopsy within 4 weeks of randomization
--Abnormal serum free-light chain ratio (< 0.26 or > 1.65) by serum FLC assay
-Patients must have measurable monoclonal protein (M-protein): greater than or equal to 1g/dL on serurm protein electrophoresis or greater than or equal to 200 mg/24 hrs urine protein electrophoresis
-Patients must have no lytic lesions or hypercalcemia
-No prior or concurrent systemic or radiation therapy for the treatment of myeloma
-Concurrent use of bisphosphonates is not permitted; however, once-a-year IV bisphosphonate for osteoporosis is permitted
-Prior or concurrent use of erythropoietin is not allowed
-Prior glucocorticosteroid therapy for MM is not allowedNo monoclonal gammopathy of undetermined significance
-Patients must not have baseline bone lesions or plasmacytomas
-Patients with monoclonal gammopathy of undetermined significance are not eligible
-ECOG performance status must be 0-2
-Patients must be felt to not have an immediate need for chemotherapy - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
E3F05
- Eligibility:Click Here to View
*Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Genesys Hurley, HurleyDISEASE CHARACTERISTICS:
Histologically confirmed* supratentorial low-grade glioma, including 1 of the following:
Grade 2 astrocytoma
Grade 2 oligodendroglioma
Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and oligodendroglioma)
NOTE: *If the pathology from multiple procedures supports the diagnosis of a brain tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma must be the most recent pathological diagnosis; no pathological diagnosis of grade 3 or 4 glioma at any time
Paraffin-embedded tumor specimen available for submission for confirmation of pathological diagnosis and determination of 1p and 19q deletion status
Patients must currently meet = 1 of the following criteria*:
Uncontrolled symptoms, defined as any of the following:
Headaches associated with mass effect
Uncontrolled seizures despite two different antiepileptic drug regimens (i.e., two antiepileptic drugs tested either sequentially or in combination)
Focal neurological symptoms
Cognitive symptoms or deficits
Tumor progression by serial MRIs, defined as any of the following:
New or progressive enhancement
New or progressive T2 or FLAIR signal abnormality
Age = 40 years
NOTE: *Patients < 40 years of age whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs AND who have no evidence of radiographic progression are not eligible.
Patients who have undergone gross total resection and have no detectable residual disease are eligible
No pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
WBC = 3,000/mm^3
ANC = 1,500/mm^3
Platelet count = 100,000/mm^3
Hematocrit = 30%
Bilirubin = 2 times upper limit of normal (ULN)
AST and ALT = 3 times ULN
Creatinine = 2.0 times ULN
Not pregnant or nursing
Negative pregnancy test
Able to undergo MRI with and without contrast
No other malignancy within the past 5 years, except for nonmelanoma skin cancer or cervical carcinoma in situ
No uncontrolled infection
No known HIV positivity
No medical disorder that would increase risks associated with radiotherapy and temozolomide
No other disorder that would limit life expectancy to < 5 years
PRIOR CONCURRENT THERAPY:
No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational therapy directed at the brain tumor
Any number of prior surgical procedures for the brain tumor allowed
No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the brain
At least 2 weeks since prior brain surgery
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Double-Blind Phase III Trial of Doxorubicin and
Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
E5103
- Eligibility:Click Here to ViewSTEP 1: Registration to Arm A, B, C
1. Patients must have histologically confirmed adenocarcinoma of the breast at
significant risk of distant recurrence based on at least one of the following criteria: Involvement of at least one axillary lymph node on routine histologic
examination. Patients with axillary node involvement only demonstrated
by immunohistochemistry are not eligible unless they meet one of the
other eligibility criteria below. ER negative tumor >1 cm, ER+ tumor > 5 cm regardless of recurrence score, ER+ tumor >1 cm but < 5 cm with a recurrence score > 11. (Patients enrolled in the TAILORx trial are eligible.)
NOTE: Premenopausal patients with ER+ tumor may participate in the
IBCSG SOFT trial. NOTE: Premenopausal patients with ER- tumor may participate in S0230.
2. Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy.
NOTE: Axillary dissection is strongly encouraged in patients with lymph node
involvement identified on sentinel node biopsy. NOTE: Breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy.
3. Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS). Patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible.
4. Interval between last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) and Day 1 of treatment must be > 28 days and < 84 days.
5. ECOG performance status of 0-1
6. Patients must have adequate organ function within < 8 weeks prior to randomization, as measured by:
Absolute neutrophil count > 1000/mm3
Platelet count > 100,000/mm3
Total bilirubin < 1.5 mg/dL
AST < 2 upper limit of normal
Serum creatinine < 1.5 mg/dL
Urine protein: creatinine (UPC) ratio <1.0*
PTT < 1.5 x normal X ULN
LVEF > institutional limits of normal by MUGA or ECHO
* Please see Appendix V for instructions on how to obtain the urine
protein:creatinine ratio
7. Patients who have undergone breast conservation surgery must receive radiation. Prior to randomization, the investigator must specify the planned radiation technique. NOTE: If APBI was completed prior to study entry, day 1 of protocol therapy must be at least 4 weeks after the completion of APBI.
8. Post-mastectomy RT is required for all patients with a primary tumor of > 5 cm or involvement of 4 or more lymph nodes. Post-mastectomy RT may be administered at the investigator?s discretion for all other mastectomy patients.
9. Patients with HER2 + (3+ by IHC or FISH+) breast cancer are not eligible.
10. Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher TNM stage tumor meets the eligibility criteria for this trial.
11. Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis.
12. Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer. Prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed. NOTE: Prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry. Similarly, prior raloxifene use is allowed but must be discontinued at study entry.
13. Patients must not have had any major surgical procedure within 28 days of day 1 treatment. NOTE: Non-operative biopsy or placement of a vascular access device is not considered a major surgery.
14. Patients may not have had placement of a vascular access device within 24 hours of planned Day 1 of treatment.
15. Patients must not have clinically significant cardiovascular or cerebrovascular disease, including:
Any history of
? Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
? Ischemic bowel
Within the last 12 months
? Myocardial infarction
? Unstable angina
? New York Heart Association (NYHA) grade II or greater congestive heart
failure
? Grade II or greater peripheral vascular disease
NOTE: See Appendix X for NYHA classification and peripheral vascular disease
grading criteria
Active at study entry
? Uncontrolled hypertension defined as SBP > 160 or DBP > 90
? Uncontrolled or clinically significant arrhythmia.
NOTE: Patients with controlled atrial fibrillation are eligible.
16. Patients who require full dose anticoagulation may enroll provided they meet the following criteria:
? the patient must have an in-range INR (usually between 2 and 3) on a stable
dose of warfarin or be on stable dose of LMW heparin.
? the patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. varices)
NOTE: Prophylactic use of anticoagulants to maintain patency of a vascular access device is permitted.
17. Patients must not have a bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy.
18. Patients must not have a non-healing wound or fracture. Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization are not eligible.
19. Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies.
20. Male or female patients age > 18 years of age are eligible.
21. Women must not be pregnant or breast-feeding due to the potential harmful effects of bevacizumab on the developing fetus. All females of childbearing potential must have a blood or urine test within 7 days prior to randomization to rule out pregnancy.
22. Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.
STEP 2: Unblinding and Re-registration to Arm D
1. Only Step I patients treated on Arm C who have not ended treatement per section 5.7 are eligible to register to Step 2, Arm D. - Consent forms:You must be logged in to view the documents.
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A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
E5202
- Eligibility:Click Here to View1. The distal extent of the tumor must be > 12 cm from the anal verge on endoscopy. If the patient is not a candidate for endoscopy, then the distal extent of the tumor must be > 12 cm from the anal verge as determined by surgical examination.
2. Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk. Tumor samples will be shipped as specified in Section 10.2. High-risk patients will be randomized to treatment Arms A or B. Low-risk patients will be registered to Arm C for observation. (Criteria noted in Sections 3.2.1 through 3.2.18 need not be met.) NOTE: Every effort should be made to submit blocks to the PCO immediately. Blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment.
3. Patients must have no history of isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted.
4. Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below: Stage II carcinoma (T3,4 N0 M0): The tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3) or directly invades other organs or structures and/or perforates visceral peritoneum (T4). Appendix IV provides TNM nomenclature and staging for colon cancer.
5. Patients must have > 8 lymph nodes evaluated and reported.
6. Patients must not have presented with complete obstruction or perforation of the bowel.
7. Patients must not have had any systemic or radiation therapy initiated for this malignancy.
8. Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease-free for > 5 years and are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization.
9. Patients must be > 18 years old.
10. Patients must have ECOG performance status of 0-2.
Step 2: Randomization (High Risk Patients ? Arms A and B only)
1. Within 2 weeks prior to randomization, postoperative absolute granulocyte count (AGC) must be > 1500/mm3 (or < 1500/mm3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal).
2. Within 2 weeks prior to randomization, the postoperative platelet count must be > 100,000/mm3.
3. Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function. Bilirubin must be < ULN unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin. Alkaline phosphatase must be < 2.5 x ULN. AST must be < 1.5 x ULN. If alkaline phosphatase or AST is > than above limits, serologic testing for Hepatitis B and C must be obtained and results must be negative.
4. Within 2 weeks prior to randomization, there must be postoperative evidence ofadequate renal function. Serum creatinine < 1.5 x ULN. Urine protein/creatinine (UPC) ratio of < 1.0. Patients with a UPC ratio > 1.0
must undergo a 24-hour urine collection, which must be an adequate collection
and must demonstrate < 1 gm of protein in order to participate. (See Appendix
VIII).
5. Patients with any significant bleeding that is not related to the primary colon tumor within 6 months prior to study entry are not eligible.
6. Patients with gastroduodenal ulcer(s) determined to be active by endoscopy are not eligible.
7. Patients with a history of hypertension must measure <150/90 mmHg and be on a stable regimen of anti-hypertensive therapy.
8. Patients must not have a serious or non-healing wound, skin ulcers or bone fracture.
9. Patients receiving concomitant halogenated antiviral agents are not eligible.
10. Patients experiencing clinically significant peripheral neuropathy at the time of step 2 randomization (defined in the NCI Common Terminology Criteria for Adverse Events version 3.0 [CTCAE 3.0] as grade 2 or greater neurosensory or neuromotor toxicity) are not eligible.
11. Patients must not have had invasive procedures, defined as follows:
Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to randomization. Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization
or anticipate the need for major surgical procedure(s) during the course of the
study.
12. Patients must begin adjuvant treatment no less than 28 days and no more than 60 days from surgery. NOTE: Every effort should be made to submit blocks to the PCO immediately. Blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment.
13. Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 3 months after the completion of bevacizumab. Women must not be pregnant or breast-feeding because the study drugs administered may cause harm to an unborn fetus or breastfeeding child. All females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks prior to step 2 randomization.3.2.14 Patients with PT (INR) > 1.5 are not eligible, unless the patient is on full-dose anticoagulants. If so, the following criteria must be met for enrollment: The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on a stable dose of low molecular weight heparin. The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding.
15. Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs are not eligible. Specifically excluded are the following conditions:
NYHA Class III or IV cardiac disease
Current symptomatic arrhythmia
Any non-malignant systemic disease
16. Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible.
17. Patients with a history of the following within twelve months of study entry are not eligible.
18. Patients with symptomatic peripheral vascular disease are not eligible.
19. Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible.
Step 2: Registration (Low-Risk Patients ? Arm C)
1. Patients determined to be low risk are eligible. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III Prospective Randomized Study Comparing Interferon Versus Allogeneic Bone Marrow Transplantation in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
E7995
- Eligibility:Click Here to View1.0) Chronic phase CML based on the presence of the Philadelphia chromosome. Patients must be in FIRST chronic phase, and NOT be in either accelerated phase or blast crisis of CML (see protocol definition).
2.0) Interval from diagnosis to enrollment on this trial must not exceed 3 months.
3.0) <61 years of age.
4.0) Previously untreated with RT or cytotoxic chemo.
Drugs: Busulfan, Cytarabine, Idarubicin, Interferon Alfa 2b, Filgrastim, Sargramostim. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
EA1131
- Eligibility:Click Here to View
Step 0 eligibility- see specific requirements for pathology:
-ECOG Performance Status must be 0 or 1
-Female and male patients must have histologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis. Note: patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol.
-Must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant treatment.
-Must have completed definitive resection of primary tumor with negative margins (or have received RT and no further surgery is possible).
-Post neoadjuvant chemotherapy, patients must have residual cancer in the breast at the time of definitive surgery. ***Please note: pathology must comment on cellularity- residual cancer must be more than minimum cellularity, preferably > 20%**
-Post-mastectomy RT is required for all patients with:
--Primary tumor greater than or equal to 5 cm or involvement of 4 or more lymph nodes at the time of definitive surgery.
-RT is required for patients who underwent breast-conserving therapy
-Must NOT have stage IV disease
-Must NOT have neuropathy greater than grade 1.
-Surgical tissue must be submitted for PAM50 analysisStep 1 Eligibility:
-Must have central PAM50 analysis by digital mRNA quantitation on residual disease
-Patients must have completed adjuvant radiotherapy greater than or equal to 2 weeks prior to randomization for protocol therapy, if applicable.
-Patients must be randomized within 24 weeks of surgeryEA1131 Arm 3 Capecitabine ARIA ordering Guide in Documents Library (SJMAA, SMML)
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
EA1151 (TMIST)
- Eligibility:Click Here to View
SJMH-Ann Arbor is the only participating site
-Women at least 45 years old and less than 75 years old
-Must be scheduled or have intent to schedule a screening mammogram
-Must not have symptoms or signs of benign or malignant breast disease
-Must not have had a screening mammogram within the last 11 mo
-Must not have previous personal history of breast cancer, including DCIS
-Must not have breast enhancements
-To be eligible for the annual screening regimen patients must meet one of the following additional criteria:
--pre-menopausal OR
-- post-menopausal aged 45-69 with risk factor: dense breasts, family history or positive genetic testing, currently on hormone therapy OR
--post-menopausal ages 70-74 with ether dense breasts or currently on hormone therapy - Consent forms:You must be logged in to view the documents.
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Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
EA2142
- Eligibility:Click Here to View
-Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma of the GI tract.
-Patients must have pathologically/histologically confirmed tumor of non-small cell histology.
-Patients must have a Ki-67 proliferative index of 20-100%
-Patients must have evidence of at least 10 mitotic figures per 10 high powered fields
-Patients must have measurable disease
-Patients may not have had any prior treatment for this malignancy.
-Patients must have an ECOG performance status of 0-2.
-Patients may not be receiving Coumadin while on treatment. Other anticoagulants are allowed.
-Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible - Consent forms:You must be logged in to view the documents.
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A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer (EA2165)
EA2165
- Eligibility:Click Here to View
*DTL Required- Physicians must sign toxicity grid
Step 1
-Patients must have histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma.
-For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer.
-Patients must have ECOG performance status of 0-2.-Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.
-Patients will be excluded if they have a T1, T2N0 or M1 cancer.
-Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
-Patient must not have active autoimmune disease that has required systemic treatment in past 2 years
Step 2
-Patients will be registered no sooner than 4 weeks following completion of standard chemoradiation for anal cancer.-Patients must have histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal (anal margin) squamous cell carcinoma.
-Patients must not have received less than 54 Gy of radiation for the treatment of the anal cancer.
-Patients must have ECOG performance status of 0-2.
- Consent forms:You must be logged in to view the documents.
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