Expired Study
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Duarte, California 91010


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer.


Study summary:

OBJECTIVES: - Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas. - Describe the toxicity of these high dose chemotherapy regimens. - Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen. - Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion. - Determine the disposition of carboplatin administered in the IC-T regimen. OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate. Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support. Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined. Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years. PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed advanced carcinomas of the following types: - Breast carcinoma that is ineligible for or patient has refused participation in a higher priority protocol in the following categories: - Stage II disease with at least 10 involved lymph nodes and no evidence of disease (NED) following surgery - Stage III disease rendered surgically NED with or without radiotherapy - Stage IV disease following partial response (PR) or complete response (CR) to surgery, chemotherapy, or radiotherapy - Prior high dose chemotherapy allowed at discretion of investigator - No chemoresistant disease rendered surgically NED - Locoregionally recurrent disease within 2 years of breast conservation with or without chemotherapy - Stage III/IV ovarian cancer - PR/CR following debulking surgery and/or chemotherapy - Ineligible for or refused participation in higher priority protocols - Primary soft tissue sarcoma with high-grade disease greater than 10 cm or that is metastatic - Rendered surgically NED or achieved PR/CR on any chemotherapeutic or immunotherapeutic regimen - Ineligible for or refused participation in higher priority protocols - Malignant melanoma in the following categories: - Ulcerative primary tumor with any number of completely resected metastatic lymph nodes - Stage II disease with more than 4 involved nodes rendered NED - Stage III disease rendered surgically NED or achieved PR/CR on any chemotherapeutic or immunotherapeutic regimen - Osteosarcoma that is ineligible for or refused participation in higher priority protocols - Resected primary with less than 50% tumor necrosis on pathologic review - Metastatic disease rendered surgically NED or PR/CR on any chemotherapeutic, radiotherapeutic, or immunotherapeutic regimen - The following diseases rendered surgically NED or that achieved PR/CR on any chemotherapeutic, radiotherapeutic, or immunotherapeutic regimen also eligible: - Small cell bone carcinoma - Metastatic Ewing's sarcoma - Metastatic gastrointestinal malignancy - Recurrent Wilms' tumor - No CNS metastases - No current histologically confirmed bone marrow metastases - Prior bone metastases with resolution at time of entry permitted PATIENT CHARACTERISTICS: Age: - Physiologic 18 to 55 Performance status: - Karnofsky 80%-100% Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 120,000/mm3 - Hemoglobin greater than 10 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - AST/ALT less than 3 times normal Renal: - Creatinine less than 1.4 mg/dL - Creatinine clearance at least 70 mL/min - No history of hemorrhagic cystitis Cardiovascular: - Ejection fraction at least 55% by MUGA - No significant cardiac disease Pulmonary: - FEV1 greater than 2 L - pO2 (room air) greater than 70 mm Hg - pCO2 (room air) less than 42 mm Hg - DLCO greater than 60% of predicted Other: - No potentially disabling psychosocial history - No organic or functional CNS dysfunction or other medical problem that would present party at undue risk - HIV negative - Hepatitis B surface antigen negative - No hearing loss greater than 40 decibels - No contraindication to the following procedures: - Collection by apheresis of up to 16 x 10 to the 8th mononuclear cells mobilized by G-CSF - Collection of autologous bone marrow, if needed - No second malignancy except: - Nonmelanomatous skin cancer - Carcinoma in situ of the cervix - Not pregnant or nursing - Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy Chemotherapy: - See Disease Characteristics - No more than 3 prior chemotherapy regimens (excluding adjuvant therapy) - No more than 200 mg per square meter of prior cisplatin - No more than 800 mg per square meter of prior carboplatin - No prior exposure to greater than 1,000 mg per square meter of "24-hour paclitaxel equivalents" (using a 1:1.3 ratio between paclitaxel doses given by 24-hour infusion and by 3-hour infusion) - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to more than 20% of bone marrow - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics


Study is Available At:


Original ID:

94098


NCT ID:

NCT00002854


Secondary ID:

P30CA033572


Study Acronym:


Brief Title:

High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer


Official Title:

PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

City of Hope Medical Center


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

33


Enrollment Type:

Actual


Overall Contact Information

Official Name:George Somlo, MD
Study Chair
Beckman Research Institute

Study Dates

Start Date:December 1994
Completion Date:August 2015
Completion Type:Actual
Primary Completion Date:August 2015
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 24, 2015
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion
Time Frame:30 days from start of course II of treatment
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion
Time Frame:30 days from start of course II of treatment
Safety Issues:True
Description:Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation
Outcome Type:Primary Outcome
Measure:Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion
Time Frame:30 days from start of course II of treatment
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:filgrastim
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:carboplatin
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:cisplatin
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:cyclophosphamide
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:etoposide
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:ifosfamide
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:mesna
Arm Name:Sequential high dose chemotherapy
Intervention Type:Drug
Name:paclitaxel
Arm Name:Sequential high dose chemotherapy
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Arm Name:Sequential high dose chemotherapy

Study Arms

Study Arm Type:Experimental
Arm Name:Sequential high dose chemotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:City of Hope Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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