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LY317615 in Treating Patients With Relapsed or Refractory Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on LY317615 in Treating Patients With Relapsed or Refractory Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. LY317615 in Treating Patients With Relapsed or Refractory Lymphoma Clinical research trials and LY317615 in Treating Patients With Relapsed or Refractory Lymphoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as LY317615 in Treating Patients With Relapsed or Refractory Lymphoma. LY317615 in Treating Patients With Relapsed or Refractory Lymphoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a LY317615 in Treating Patients With Relapsed or Refractory Lymphoma clinical trial. Human subjects often receive the most effective healthcare possible for their LY317615 in Treating Patients With Relapsed or Refractory Lymphoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > LY317615 in Treating Patients With Relapsed or Refractory Lymphoma  LY317615 in Treating Patients With Relapsed or Refractory Lymphoma
LY317615 in Treating Patients With Relapsed or Refractory Lymphoma
For Condition: recurrent adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of LY317615 in treating patients who have relapsed or refractorylymphoma.
Details: OBJECTIVES: - Determine the clinical response rate (freedom from progression for at least 2 courses) in patients with relapsed or refractory diffuse large B-cell lymphoma treated with LY317615. - Determine the objective response rate (complete and partial) in patients treated with this drug. - Determine the safety of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Evaluate the efficacy of this drug, in terms of B symptoms and/or other tumor-related symptoms, in these patients. - Determine the duration of overall response and progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral LY317615 once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of therapy at the discretion of the primary investigator. Patients are followed at 30 days. Patients with stable disease or at least partial response are also followed every 4-8 weeks until disease progression or initiation of another therapy. PROJECTED ACCRUAL: Approximately 19-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Morphologically confirmed diffuse large B-cell lymphoma - Relapsed disease after treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), CHOP-based chemotherapy or equivalent, or salvage therapy, indicated by one of the following: - Radiographic progression after a complete response to CHOP - Best response to CHOP of partial response or stable disease with clinical or radiographic evidence of active disease - Must not have progressed while receiving CHOP or a CHOP-equivalent regimen - Must not be a candidate for high-dose chemotherapy and autologous stem cell transplantation - Bidimensionally measurable disease by physical exam or CT scan - No HIV-associated lymphomas - No known or symptomatic CNS or leptomeningeal metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal - Creatinine less than 2 times ULN - Calcium at least 8.4 mg/dL - Potassium at least 3.4 mEq/L - Magnesium at least 1.2 mEq/L Cardiovascular - QTc interval no greater than 450 msec for males (470 msec for females) - No other electrocardiogram abnormalities - No clinically significant cardiac symptomatology Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3-6 months after study participation - Must be able to swallow capsules - No active bacterial, fungal, or viral infection that would preclude study participation - No other serious concurrent disorder - No other primary malignancy within the past 5 years except adequately treated basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior rituximab allowed - Rituximab administered alone or in combination with cytotoxic chemotherapy is not considered a prior regimen - Prior high-dose chemotherapy with stem cell transplantation (SCT) allowed (provided patient has not progressed within 3 months of SCT*) - No concurrent immunotherapy NOTE: *Conventional salvage therapy with mobilization and SCT are considered 1 regimen Chemotherapy - See Disease Characteristics - See Biologic therapy - No more than 2 prior chemotherapy regimens - At least 30 days since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 30 days since prior anticancer radiotherapy and recovered - No concurrent radiotherapy, including palliative radiotherapy Surgery - Not specified Other - At least 30 days since prior anticancer investigational therapies or drugs and recovered - No other concurrent experimental medications - No other concurrent antitumor therapies - No other concurrent therapeutic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristosEmmanouilides, Principal Investigator, Jonsson Comprehensive Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Mary Laughlin 216-844-8609
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Christos Emmanouilides 310-206-0716
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
Additional Information:
Study ID Numbers: CDR0000269880; LILLY-H6Q-MC-JCA,UNMC-18502,LILY-1402,UCLA-0210010,CWRU-080213J
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054080
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Ifosfamide, Teniposide, and Paclitaxel in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
2. Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
3. Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
4. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
5. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
LY317615 in Treating Patients With Relapsed or Refractory Lymphoma
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