NCT00093405

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

June 24, 2013

Status Verified

November 1, 2005

First QC Date

October 6, 2004

Last Update Submit

June 21, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage IV renal cell cancerclear cell renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Efficacy (complete and partial response)

Secondary Outcomes (1)

  • Toxicity

Interventions

tanespimycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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. doi: 10.1007/s10637-006-9208-z.

    PMID: 16832603RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Gnanamba V. Kondagunta, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

August 1, 2004

Study Completion

November 1, 2005

Last Updated

June 24, 2013

Record last verified: 2005-11

Locations

US(1)