NCT00004063

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia and how well they work in treating patients with metastatic, recurrent, or refractory cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

April 30, 2009

Status Verified

December 1, 2008

Enrollment Period

12.3 years

First QC Date

December 10, 1999

Last Update Submit

April 29, 2009

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (5)

  • Response duration

  • Duration of stable disease

  • Overall survival

  • Progression-free survival

  • Time to response

Interventions

recombinant interferon alfaBIOLOGICAL
cisplatinDRUG
gemcitabine hydrochlorideDRUG
hyperthermia treatmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic, recurrent, or refractory carcinoma * Measurable disease by CT, MRI, or physical examination * No brain metastases or other CNS disorders PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 90,000/mm\^3 * Bone marrow cellularity normal on bone marrow biopsy * No coagulopathy disorder Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT no greater than 2 times upper limit of normal * PT less than 14 seconds * PTT less than 35 seconds * No inadequate liver function (no greater than 20% involvement) Renal: * Creatinine no greater than 1.8 mg/dL * Creatinine clearance at least 45 mL/min * BUN no greater than 25 mg/dL Cardiovascular: * Adequate cardiac function documented by history, physical exam, or stress exercise test (MUGA or ECHO) with resting blood pressure and heart rate increasing appropriately with exercise * LVEF at least 45% * No prior myocardial infarction * No symptomatic coronary artery disease * No angina * No significant arrhythmia * No uncontrolled hypertension * No thromboembolic disease Pulmonary: * FEV\_1 at least 70% of predicted * Arterial PO\_2 at least 60 mmHg on room air * No massive (greater than 30% involvement) lung disease * DLCO greater than 50% of predicted Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No seizure disorders * No significant emotional instability * No history of malignant hyperthermia following general anesthesia * No other concurrent medical illness that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * At least 6 days since major thoracic or abdominal surgery Other: * No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin

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

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77225, United States

RECRUITING

MeSH Terms

Interventions

Interferon-alphaCisplatinGemcitabineDiathermy

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHyperthermia, InducedTherapeutics

Study Officials

  • Joan M.C. Bull, MD

    The University of Texas Health Science Center, Houston

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

November 1, 2011

Last Updated

April 30, 2009

Record last verified: 2008-12

Locations

US(1)