Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Brief Summary

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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

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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

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (tanespimycin)

Patients will receive infusions of tanespimycin analogue twice a week in weeks 1 and 3.

Group Type EXPERIMENTAL

tanespimycin

Intervention Type DRUG

Given IV

Interventions

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tanespimycin

Given IV

Intervention Type DRUG

Other Intervention Names

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17-AAG

Eligibility Criteria

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Inclusion Criteria

Criteria:

* Platelet count at least 100,000/mm\^3
* No leukemia
* No active CNS involvement with tumor
* ECOG 0-2
* Life expectancy: at least 3 months
* Absolute neutrophil count at least 2,000/mm\^3
* No New York Heart Association class III or IV heart failure
* No history of myocardial infarction within the past year
* Bilirubin =\< upper limit of normal (ULN)
* AST no greater than 2 times ULN (no greater than 98 U/L)
* No uncontrolled dysrhythmias
* No poorly controlled angina
* No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) \>= 3 beats in a row)
* QTc interval =\< 450 msec for men or =\< 470 msec for women
* LVEF \>= 40% by MUGA
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No other serious medical condition that would preclude study participation
* No serious hypersensitivity to egg products
* No concurrent anticancer immunotherapy
* At least 4 weeks since prior chemotherapy and recovered
* No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone \[CHOP\] or mechlorethamine, vincristine, procarbazine, and prednisone \[MOPP\])
* No concurrent anticancer hormonal therapy
* Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* No concurrent major surgery
* No concurrent anticancer glucocorticoids
* Creatinine =\< ULN or Creatinine clearance at least 60 mL/min
* No concurrent medications that cause QTc prolongation
* Histologically confirmed advanced solid tumor for which no curative therapy exists
* Non-Hodgkin's lymphoma allowed
* No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Grem

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States