17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00089271

First received: August 4, 2004

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2004

Last Updated Date

January 24, 2013

Start Date ^ICMJE

July 2004

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose of alvespimycin hydrochloride [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Toxicity graded using the NCI CTCAE version 3.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics of alvespimycin hydrochloride in blood, urine, and tumor tissue [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Analyzed by both non-compartmental and compartmental methods.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00089271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tumor response assessed by tumor measurements [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas

Official Title ^ICMJE

A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors

Brief Summary

This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or die

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors or lymphomas.

II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

IV. Determine the recommended phase II dose of this drug for future studies.

SECONDARY OBJECTIVES:

I. Determine tumor response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.

Patients are followed at 4 weeks.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell 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 Hodgkin Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage III Small Lymphocytic 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 Hodgkin Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome
Stage IV Small Lymphocytic Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Waldenström Macroglobulinemia

Intervention ^ICMJE

Drug: alvespimycin hydrochloride
Given IV
Other Names:
- 17-DMAG HCL
- KOS-1022
Other: laboratory biomarker analysis
Correlative studies

Study Arm (s)

Experimental: Treatment (alvespimycin hydrochloride)

Interventions:

Drug: alvespimycin hydrochloride
Other: laboratory biomarker analysis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically confirmed solid tumor or lymphoma
- Metastatic or unresectable disease
Standard curative or palliative measures do not exist or are no longer effective
No known brain metastases
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
More than 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
ALT and AST ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ normal
Creatinine ≤ 1.25 times ULN
Creatinine clearance ≥ 60 mL/min
QTc < 450 msec for male patients (470 msec for female patients)
LVEF > 40% by MUGA
No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
No myocardial infarction or active ischemic heart disease within the past year
No New York Heart Association class III or IV congestive heart failure
No poorly controlled angina
No uncontrolled dysrhythmia requiring medication
No left bundle branch block
No history of congenital long QT syndrome
No other significant cardiac disease
Pulse oximetry at rest or on exercise > 88%
No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed:
- Pulmonary disease requiring medication
- History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea
- Patients meeting the Medicare criteria for home oxygen or are on oxygen
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation
No uncontrolled illness
No active or ongoing infection
No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG)
No psychiatric illness or social situation that would preclude study compliance
No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Concurrent hormonal therapy allowed
At least 4 weeks since prior radiotherapy and recovered
No prior radiation that included the heart in the field (e.g., mantle)
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer agents or therapies
No concurrent medication that would prolong the QTc interval
No other concurrent investigational agents

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00089271

Other Study ID Numbers ^ICMJE

NCI-2012-02620, PCI-03-153, U01CA069912, U01CA099168, U01CA062502, CDR0000378189

Has Data Monitoring Committee

Not Provided

Responsible Party

National Cancer Institute (NCI)

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Chandra Belani

University of Pittsburgh

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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