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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Maximum tolerated dose of alvespimycin hydrochloride [ Time Frame: 21 days ]
  • Toxicity graded using the NCI CTCAE version 3.0 [ Time Frame: Up to 4 weeks ]
  • Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments [ Time Frame: 21 days ]
  • Pharmacokinetics of alvespimycin hydrochloride in blood, urine, and tumor tissue [ Time Frame: 21 days ]
    Analyzed by both non-compartmental and compartmental methods.


Original Primary Outcome:

Current Secondary Outcome: Tumor response assessed by tumor measurements [ Time Frame: Up to 4 weeks ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 4, 2004
Date Started: July 2004
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013