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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 HoustonHouston, Texas  77225