Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over Other UTHSC-MS-99116 NCI-V99-1561, NCT00004063

Objectives

1. 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).

Entry 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

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

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/mm³
• Platelet count at least 90,000/mm³
• 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:

• FEV₁ at least 70% of predicted
• Arterial PO₂ 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

Expected Enrollment

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

Outcomes

Response duration
Duration of stable disease
Overall survival
Progression-free survival
Time to response

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.

Trial Contact Information

Trial Lead Organizations

University of Texas Health Science Center at Houston

Joan Bull, MD, Protocol chair		Ph: 713-500-6820 Email: joan.m.bull@uth.tmc.edu

U.S.A.
Texas
	Houston
	University of Texas Health Science Center at Houston
		Joan Bull, MD	Ph:  713-500-6820
			Email: joan.m.bull@uth.tmc.edu

Registry Information
Official Title		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
Trial Start Date		1999-08-01
Registered in ClinicalTrials.gov		NCT00004063
Date Submitted to PDQ		1999-07-29
Information Last Verified		2008-07-18