NCT00006968

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

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

September 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

June 27, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

December 6, 2000

Last Update Submit

January 7, 2013

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Interventions

filgrastimBIOLOGICAL
cyclosporineDRUG
pentostatinDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced renal cell cancer * No bone metastases * No CNS disease * Must have an allogeneic donor available PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * 3 to 6 months Hematopoietic: * Hemoglobin at least 10 g/dL * Complete blood count normal Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN) * Transaminases no greater than 4 times ULN * No evidence of portal hypertension Renal: * Creatinine no greater than 2.0 mg/dL * No uncontrolled hypercalcemia Cardiovascular: * No New York Heart Association class 3 or 4 heart disease Pulmonary: * DLCO at least 40% of predicted Other: * No severe functional neurological impairment * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic therapy Chemotherapy: * No more than 6 months of prior chemotherapy Endocrine therapy: * At least 1 year since prior steroids Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1678, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

FilgrastimCyclosporinePentostatinPeripheral Blood Stem Cell Transplantation

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)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsCoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Gary J. Schiller, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2000

First Posted

June 27, 2003

Study Start

September 1, 2000

Primary Completion

September 1, 2004

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(1)