Trials / Terminated
TerminatedNCT00019708
Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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. Patients receive geldanamycin analogue (AAG) IV over 1-6 hours once daily on days 1, 4, 15, and 18. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 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. Once the MTD is determined, an additional 10 patients are treated at the MTD. Patients are followed every 6 weeks.
Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Non-Hodgkin Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Small Lymphocytic Lymphoma
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tanespimycin | Given IV |
Timeline
- Start date
- 1999-06-01
- Primary completion
- 2010-04-01
- First posted
- 2003-01-27
- Last updated
- 2013-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00019708. Inclusion in this directory is not an endorsement.