Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI PCI-99-020 NCI-T99-0038, NCT00004241, T99-0038

Objectives

1. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma.
2. Determine the significant toxic effects associated with this drug in these patients.
3. Determine the response in patients treated with this drug.
4. Determine the pharmacokinetics of 17-AAG and 17AG in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists



• Brain metastases allowed after definitive radiotherapy

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior biologic therapy (regional or systemic)

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
• No active infection
• No other serious concurrent condition
• No prior allergic reaction to egg products

Expected Enrollment

A maximum of 60 patients will be accrued for this study.

Outline

This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules.

• Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.



• Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

In both schedules, cohorts of 3-6 patients receive escalating doses of 17-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. At least 6 patients receive treatment at the MTD.

Ramanathan RK, Egorin MJ, Eiseman JL, et al.: Phase I and pharmacodynamic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with refractory advanced cancers. Clin Cancer Res 13 (6): 1769-74, 2007.[PUBMED Abstract]

Ramanathan RK, Belani CP, Friedland D, et al.: Phase I study (twice weekly schedule) of 17-allylamino-17 demethoxygeldanamycin (17AAG, NSC-704057) in patients with advanced refractory tumors. [Abstract] J Clin Oncol 23 (Suppl 16): A-3050, 204s, 2005.

Ramanathan RK, Trump DL, Eiseman JL, et al.: A phase I pharmacokinetic (PK) and pharmacodynamic (PD) trial of weekly 17-allylamino-17 demethoxygeldanamycin (17AAG, NSC-704057) in patients with advanced tumors. [Abstract] J Clin Oncol 22 (Suppl 14): A-3031, 202s, 2004.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

Ramesh Ramanathan, MD, Protocol chair		Ph: 412-648-6507

Registry Information
Official Title		A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin
Trial Start Date		1999-12-15
Registered in ClinicalTrials.gov		NCT00004241
Date Submitted to PDQ		1999-12-23
Information Last Verified		2005-02-21
NCI Grant/Contract Number		CA47904

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