Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 treating patients with metastatic or unresectable solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

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