17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093405
First received: October 6, 2004
Last updated: June 21, 2013
Last verified: November 2005

October 6, 2004
June 21, 2013
August 2004
Not Provided
Efficacy (complete and partial response) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00093405 on ClinicalTrials.gov Archive Site
Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney Cancer
A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. 17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer.

OBJECTIVES:

Primary

  • Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic papillary or clear cell renal cell carcinoma.

Secondary

  • Determine the safety of this drug in these patients.
  • Correlate tumor c-met expression with response in patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to histology (papillary vs clear cell).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 6-20 months (clear cell stratum) and 2-5 years (papillary stratum).

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
Drug: tanespimycin
Not Provided
Ronnen EA, Kondagunta GV, Ishill N, Sweeney SM, Deluca JK, Schwartz L, Bacik J, Motzer RJ. A phase II trial of 17-(Allylamino)-17-demethoxygeldanamycin in patients with papillary and clear cell renal cell carcinoma. Invest New Drugs. 2006 Nov;24(6):543-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2005
Not Provided

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Papillary OR clear cell histology

      • If other histologies are present, clear cell or papillary must be predominant
    • Metastatic disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No brain metastases unless previously treated with radiotherapy or surgery AND asymptomatic with no active brain metastases detectable by CT scan or MRI for ≥ 6 months

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 2.0 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No severe valvular disease

Pulmonary

  • No severe debilitating pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy to egg or egg products
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
  • No active or ongoing infection requiring IV antibiotics
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior cytokine-based regimen
  • No concurrent biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • More than 4 weeks since prior major surgery

Other

  • Recovered from prior therapy
  • No more than 1 prior non-cytokine-based regimen
  • No other prior systemic treatment regimens
  • No other concurrent cytotoxic therapy
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00093405
CDR0000387952, MSKCC-04082, NCI-6479
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center.
National Cancer Institute (NCI)
Study Chair: Gnanamba V. Kondagunta, MD Memorial Sloan Kettering Cancer Center.
National Cancer Institute (NCI)
November 2005

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