Clinical trial · Interventional
Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors (10038414)
NCT00112476CI-TRIAL-00010204completedPhase 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)
This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bryostatin, temsirolimus)
- description
- Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bryostatin 1
- Drug: temsirolimus
Primary outcomes (1)
- measure
- MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0
- timeFrame
- 28 days
- description
- A dose-limiting toxicity is defined as a toxicity that is \>= grade 3 and drug-related.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed solid tumor, including melanoma or renal cell carcinoma
* Metastatic or unresectable disease
* Must have evidence of residual, recurrent, or metastatic disease by radiography
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT scan, MRI, or x-ray) OR ≥ 10 mm by spiral CT scan
* Must show clear evidence of disease progression within the lesion if the only site of measurable disease is within a previously irradiated volume
* Standard curative or palliative measures do not exist OR are no longer effective
* No history of or known brain metastases
* Performance status - ECOG 0-1
* At least 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin normal
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 50 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Fasting cholesterol ≤ 350 mg/dL\*
* Triglycerides ≤ 400 mg/dL\*
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective contraception for ≥ 1 month before, during, and for ≥ 3 months after completion of study treatment (during and for ≥ 3 months after completion of study treatment for male patients)
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
* No ongoing or active bacterial or viral infection
* No psychiatric illness or social situation that would preclude study compliance
* No dementia or altered mental status that would preclude giving informed consent
* No other uncontrolled illnesses
* More than 3 weeks since prior immunotherapy
* Prior biological therapy (e.g., interferon or interleukin 2, vaccine, antibody-based and tyrosine kinase inhibitors) allowed
* No concurrent prophylactic hematopoietic colony-stimulating factors except for epoetin alfa
* No prior cytotoxic chemotherapy
* No prior bryostatin 1, temsirolimus, everolimus, or AP23573 for this malignancy
* More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No concurrent steroids except for topical or inhaled use
* No other concurrent experimental agents
* No prior radiotherapy to \> 25% of bone marrow
* More than 3 weeks since prior radiotherapy
* More than 3 weeks since prior major surgery, including nephrectomy
* Minor surgical procedures allowed
* Recovered from prior therapy
* More than 3 weeks since prior other anticancer investigational agents
* Concurrent CYP3A4 inducers or inhibitors allowed provided patient has been on a stable dose for ≥ 1 week before study entry
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent antineoplastic agents or therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.