Clinical trial · Interventional
Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)
NCT00004144CI-TRIAL-00014337completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bryostatin 1 & gemcitabine hydrochloride
- interventionNames
- Drug: bryostatin 1
- Drug: gemcitabine hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies * Measurable or evaluable disease * Clinically controlled brain metastases allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 8.0 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal) * AST less than 2.5 times ULN Renal: * Creatinine normal Cardiovascular: * No active cardiac disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent bacterial infection requiring antibiotics * No serious concurrent medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapy allowed * No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids) Radiotherapy: * At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered * No concurrent radiotherapy Surgery: * Recovered from prior major surgery Other: * No concurrent antiviral nucleosides * At least 1 month since prior investigational agents * No other concurrent experimental medications
References
Publications (1)
- RESULTEl-Rayes BF, Gadgeel S, Shields AF, Manza S, Lorusso P, Philip PA. Phase I study of bryostatin 1 and gemcitabine. Clin Cancer Res. 2006 Dec 1;12(23):7059-62. doi: 10.1158/1078-0432.CCR-06-1419. PMID 17145828