Status:
COMPLETED
Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in ...
Detailed Description
OBJECTIVES: Primary * Determine the pharmacodynamic optimal dose of sirolimus, by evaluating p70\^s6 kinase inhibition in peripheral blood mononuclear cells (PBMC) and normal skin, in patients with ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor malignancy
- Metastatic or inoperable disease
- Failed curative or standard palliative therapy OR no such therapy exists
- Evaluable or measurable disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Tumor amenable to serial biopsies
- No known brain metastases
- PATIENT CHARACTERISTICS:
- ECOG 0-1
- Life expectancy ≥ 3 months
- WBC \> 3,500/mm³
- Absolute neutrophil count \> 1,500/mm³
- Hemoglobin \> 9 g/dL
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2 mg/dL
- ALT and AST ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- Triglycerides \< 2 times ULN
- Total cholesterol \< 2 times ULN
- Willing to undergo serial tumor biopsies and normal skin biopsies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No immunodeficiency
- No gastrointestinal tract disease resulting in an inability to take oral medication
- No requirement for IV alimentation
- No active peptic ulcer disease
- No active infections
- No other uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy
- No concurrent or second malignancy within the past 5 years
- No clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction within the past 12 months
- Unstable angina
- Peripheral vascular disease ≥ grade 2
- Uncontrolled congestive heart failure
- Uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 170 mm Hg, diastolic BP \> 95 mm Hg)
- PRIOR CONCURRENT THERAPY:
- Recovered from prior anticancer therapy
- No unresolved chronic toxicity \> CTC grade 2
- No prior surgical procedures affecting absorption
- More than 4 weeks since prior surgery except minor procedures (e.g., dental work or skin biopsy)
- More than 1 month since prior participation in an investigational drug trial
- More than 1 month since prior chemotherapy
- No concurrent use of any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Cyclosporine
- Clarithromycin
- Diltiazen
- Clotrimazole
- Ketoconazole
- Fluconazole
- Hypericum perforatum (St. John's wort)
- Cimetidine
- Grapefruit juice
- No concurrent immunosuppressants
- No other concurrent investigational or commercial agents or therapies for this malignancy
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00368914
Start Date
December 1 2004
End Date
June 1 2009
Last Update
August 9 2010
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410