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Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma Clinical research trials and Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma. Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma  Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
For Condition: adult solid tumor,Lymphoma,Leukemia,small intestine cancer
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 and interleukin-2 in treating patients who have refractorysolid tumors or lymphoma.
Details: OBJECTIVES: - Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas. - Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients. - Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells. - Assess any anti-tumor response in these patients treated with this regimen. OUTLINE: This is a dose escalation study of interleukin-2. Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists - Prostate cancer patients must have the following: - Tumor progression following blockade of both testicular and adrenal androgens - Serum testosterone in the castrate range (less than 20 ng/mL) - At least 3 months since prior suramin therapy - At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment - Luprolide should continue if no prior orchiectomy - No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0 or 1 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,500/mm OR - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Hepatitis B surface antigen negative - PT no greater than 14 seconds - PTT no greater than 35 seconds - Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease - SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Albumin at least 2.5 g/dL Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min - Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL Cardiovascular: - No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment - No evidence of CAD on EKG Pulmonary: - FEV1-1 at least 70% predicted - DLCO at least 60% predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - At least 1 week since active infection requiring antibiotics - No other medical or psychiatric condition that would preclude study - No prior or concurrent seizure disorders controlled with medication PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior interleukin-2 - At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior bryostatin 1 - At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas Endocrine therapy: - See Disease Characteristics - At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas - No absolute requirement for corticosteroids Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy for solid tumors or lymphomas Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery for solid tumors or lymphomas Other: - No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IgorEspinoza-Delgado, Study Chair, National Institute on Aging (NIA)
National Institute on Aging *Recruiting*
Baltimore, Maryland, 21224-6825
United States
Recruiting Igor Espinoza-Delgado 410-558-8190
Additional Information:
Study ID Numbers: CDR0000067198; NCI-T99-0015,LSUMC-9901
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003993
Other Adult Solid Tumor Studies:
1. Decitabine in Treating Patients With Advanced Solid Tumors
2. Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
3. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
4. VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
5. Docetaxel in Treating Patients With Solid Tumors
Related Studies:
Other adult solid tumor Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
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