Clinical trial · Interventional
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| bryostatin 1 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available