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

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

recombinant interferon alfa

cisplatin

gemcitabine hydrochloride

hyperthermia treatment

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific focused on measuring unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Texas Health Science Center at HoustonRecruiting

Outcomes

Primary Outcome Measures

Response duration

Duration of stable disease

Overall survival

Progression-free survival

Time to response

Secondary Outcome Measures

Full Information

NCT ID

NCT00004063

First Posted

December 10, 1999

Last Updated

April 29, 2009

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT00004063

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 1999 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

recombinant interferon alfa

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Procedure

Intervention Name(s)

hyperthermia treatment

Primary Outcome Measure Information:

Title

Response duration

Title

Duration of stable disease

Title

Overall survival

Title

Progression-free survival

Title

Time to response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joan M.C. Bull, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Study Chair

Facility Information:

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77225

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joan M.C. Bull, MD

Phone

713-500-6820

Email

joan.m.bull@uth.tmc.edu

Unspecified Adult Solid Tumor, Protocol Specific

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial