Status:
COMPLETED
Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Recurrent Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 che...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumor...
Eligibility Criteria
Inclusion
- 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 therapies
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00112476
Start Date
March 1 2005
Last Update
May 3 2013
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497