Know Cancer

or
forgot password

A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma


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).

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy (complete and partial response)

Safety Issue:

No

Principal Investigator

Gnanamba V. Kondagunta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000387952

NCT ID:

NCT00093405

Start Date:

August 2004

Completion Date:

November 2005

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021