Recruiting
Phase 1
Phase 2

Cisplatin, Gemcitabine, Interferon Alfa, Hyperthermia

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00004063

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

recombinant interferon alfa

cisplatin

gemcitabine hydrochloride

hyperthermia treatment

Study Details

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study ID

NCT00004063

Start date

Aug, 1999

Status verified date

Dec, 2008

Primary completion date

Nov, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

recombinant interferon alfa

cisplatin

gemcitabine hydrochloride

hyperthermia treatment

Primary outcome measure

  • Response duration [ Time Frame: undefined ]
  • Duration of stable disease [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]
  • Progression-free survival [ Time Frame: undefined ]
  • Time to response [ Time Frame: undefined ]

Central Contacts and Locations

Locations

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77225

Contacts

Joan M.C. Bull, MD

713-500-6820joan.m.bull@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 30, 2009

Last verified

Dec, 2008

Keywords

  • unspecified adult solid tumor, protocol specific

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2009-04-30.