Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21224


Purpose:

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: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.


Study summary:

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.


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^3 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


NCT ID:

NCT00003993


Primary Contact:

Study Chair
Igor Espinoza-Delgado, MD
Gerontology Research Center


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.