RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have advanced epithelial cancer, malignant lymphoma, or sarcoma.

Condition	Treatment or Intervention	Phase
Cancer	Drug: 17-N-allylamino-17-demethoxygeldanamycin  Procedure: chemotherapy	Phase I

OBJECTIVES:

• Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma.
• Determine the significant toxic effects associated with this drug in these patients.
• Determine the response in patients treated with this drug.
• Determine the pharmacokinetics of 17-AAG and 17AG in these patients.

OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules.

• Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. In both schedules, cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients receive treatment at the MTD.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
• Brain metastases allowed after definitive radiotherapy

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
• No active infection
• No other serious concurrent condition
• No prior allergic reaction to egg products

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 4 weeks since prior biologic therapy (regional or systemic)

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study chairs or principal investigators

Ramesh K. Ramanathan, MD,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000067486; PCI-99-020; NCI-T99-0038
Record last reviewed:  August 2004
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00004241
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29