NCT00045370

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

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

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

September 6, 2002

Last Update Submit

June 4, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage III renal cell cancerstage IV renal cell cancer

Interventions

recombinant interferon alfaBIOLOGICAL
temsirolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced or metastatic renal cell cancer * Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease * Measurable or evaluable disease * No concurrent CNS metastases * Prior CNS metastases allowed if no residual disease by MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal * Creatinine less than 2 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No unstable angina * No myocardial infarction within the past 6 months Other * Cholesterol no greater than 350 mg/dL * Triglycerides no greater than 400 mg/dL * HIV negative * Not immunocompromised * No active autoimmune disorder * No active infection requiring antibiotic therapy * No other serious concurrent illness * No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs * No other major illness that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 3 weeks since prior immunotherapy * No prior interferon alfa * No other concurrent immunotherapy * No prophylactic growth factors * Concurrent epoetin alfa allowed Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior CCI-779 * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed) * Concurrent inhaled or replacement steroids allowed Radiotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * See Disease Characteristics * At least 3 weeks since prior immunosuppressive agents * At least 4 weeks since prior investigational agents * No other concurrent investigational agents * No concurrent immunosuppressive therapy * No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide * No concurrent maintenance therapy for life-threatening ventricular arrhythmia

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

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Interferon-alphatemsirolimus

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

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert J. Motzer, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)