Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The University of Texas Health Science Center, Houston
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004063
First received: December 10, 1999
Last updated: April 29, 2009
Last verified: December 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant interferon alfa Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: hyperthermia treatment |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Interferon
Cisplatin
Interferon Alfa-2a
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response duration [ Designated as safety issue: No ]
- Duration of stable disease [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 1999 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004063
Locations
| United States, Texas | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77225 | |
| Contact: Joan M.C. Bull, MD 713-500-6820 joan.m.bull@uth.tmc.edu | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
| Study Chair: | Joan M.C. Bull, MD | The University of Texas Health Science Center, Houston |
More Information
Additional Information:
No publications provided
| Responsible Party: | Joan M.C. Bull, University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT00004063 History of Changes |
| Obsolete Identifiers: | NCT00005929 |
| Other Study ID Numbers: | CDR0000067264, UTHSC-MS-99116, NCI-V99-1561 |
| Study First Received: | December 10, 1999 |
| Last Updated: | April 29, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Fever Body Temperature Changes Signs and Symptoms Interferon-alpha Interferon Alfa-2a Interferons Gemcitabine Cisplatin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors |
Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Radiation-Sensitizing Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013