Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer

The University of Texas System (UT)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: gemcitabine hydrochloride

Biological: recombinant interferon alfa

Procedure: hyperthermia treatment

Drug: cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00004063

NCI-V99-1561

CDR0000067264

UTHSC-MS-99116

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the toxicity and tumor response in patients with metastatic, recurrent, or refractory malignancies treated with cisplatin, gemcitabine, interferon alfa, and long-duration, low temperature whole body hyperthermia (LL-WBH).

OUTLINE: This is a dose escalation study of cisplatin.

Phase I and II: Patients receive gemcitabine IV over 30 minutes on day 1 and 8. Patients receive cisplatin IV over 6 hours on day 15, followed by subcutaneous interferon alfa on days 16 and 17. Patients undergo long-duration, low temperature whole body hyperthermia over 6 hours plus gemcitabine over 30 minutes on day 17. Courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity.
Phase I: Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The MTD of cisplatin is used for phase II study.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: