NCT00019708TerminatedPhase 1
A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors
National Cancer Institute (NCI)1 site in 1 country45 target enrollmentStarted: June 1999Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose of tanespimycin
Study Overview
Brief Summary
Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of geldanamycin analogue (AAG) in patients with advanced solid tumors.
II. To determine the toxic effects of this drug in this patient population. III. To determine the biochemical and molecular effects of this drug in normal and accessible tumor tissue in these patients.
IV. To determine the pharmacokinetics of this drug in these patients. V. To assess any antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (tanespimycin)
Experimental
Patients will receive infusions of tanespimycin analogue twice a week in weeks 1 and 3.
Intervention: tanespimycin (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose of tanespimycin
Time Frame: 28 days
DLT are defined as any greater than or equal to grade 3 non-hematologic toxicity (except for alopecia of any grade, grade 3 nausea or vomiting during less than maximal antiemetic therapy, and grade 3 fever in the absence of neutropenia and infection), any grade 4 hematologic toxicity (except for anemia of any grade), or the inability to resume treatment by day 42 (longer than two week delay) because of drug related toxicity.
Secondary Outcomes
- Biomolecular effects of tanespimycin in normal tissues such as peripheral blood and bone marrow mononuclear cells(Up to day 5)
- Pharmacokinetics of tanespimycin(Pre-infusion, 20 minutes, 40, 50, 60 (end of infusion), 70, 80, 95 and 110 minutes, and 2.5, 3, 4, 5, 6.5, 8, 10, 14 and 24 hours)
Investigators
Study Sites (1)
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