17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
This study is currently recruiting patients.
Sponsored by: |
University of Pittsburgh Cancer Institute
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Advanced Epithelial Cancer, Malignant
Lymphoma, or Sarcoma
Further Study Details:
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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:
Performance status:
Life expectancy:
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:
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
Location
and Contact
Information
Pennsylvania Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,
Pennsylvania,
15232,
United States; Recruiting
Ramesh K. Ramanathan, MD
412-648-6507
Study chairs or principal investigators
Ramesh K. Ramanathan, MD, Study Chair, University of Pittsburgh Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000067486; PCI-99-020; NCI-T99-0038
Record last reviewed:
August 2004
Record first received:
January 28, 2000
ClinicalTrials.gov Identifier:
NCT00004241Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-18