Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Topotecan may stop the growth of solid tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying how well topotecan works in treating patients with metastatic or unresectable solid tumors.


Study summary:

OBJECTIVES: Primary - Determine whether chronic administration of topotecan inhibits hypoxia inducible factor-1α (HIF-1α) in patients with metastatic or unresectable solid tumors expressing HIF-1α. Secondary - Determine tumor angiogenesis using dynamic contrast-enhanced MRI in patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. - Determine tumor response in patients treated with this drug. OUTLINE: This is a pilot study. Patients receive oral topotecan once daily on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients who are in remission are followed every 3 months until the start of salvage therapy. PROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor - Metastatic or unresectable disease - Progressive disease after prior standard therapy OR no standard therapy exists - Hypoxia inducible factor-1α (HIF-1α)-expressing tumor by immunohistochemistry, defined as > 10% of cells staining positive for HIF-1α - Tumor accessible by biopsy with minimal or small amount of risk to the patient - No known brain metastases - Previously treated brain metastases that have remained stable for ≥ 4 months without steroids or antiseizure medication allowed at the discretion of the investigator PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - PT and PTT ≤ 1.5 times ULN Renal - Creatinine ≤ 1.5 mg/dL OR - Creatinine clearance ≥ 50 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - No known immune deficiency syndrome - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to topotecan or to any component of the topotecan formulation - No active peptic ulcer or gastrointestinal condition that could alter absorption or motility - No other unstable medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior anticancer vaccines Chemotherapy - More than 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or UCN-01) - No concurrent chemotherapy Endocrine therapy - More than 4 weeks since prior anticancer hormonal therapy except gonadotropin-releasing hormone agonists - Concurrent androgen suppression for the treatment of prostate cancer allowed Radiotherapy - More than 4 weeks since prior anticancer radiotherapy Surgery - Not specified Other - Recovered from prior therapy - No prior topotecan - At least 2 weeks since prior and no other concurrent investigational agents administered as part of a phase 0 study - No concurrent herbal or alternative medications except a single daily multivitamin


NCT ID:

NCT00182676


Primary Contact:

Study Chair
Giovanni Melillo, MD
National Cancer Institute - Frederick


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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