A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies
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.
Inclusion 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:
- 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Response duration
Safety Issue:
No
Principal Investigator
Joan M.C. Bull, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The University of Texas Health Science Center, Houston
Authority:
Unspecified
Study ID:
CDR0000067264
NCT ID:
NCT00004063
Start Date:
August 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Fever
Name | Location |
|---|---|
| University of Texas Health Science Center at Houston | Houston, Texas 77225 |
