Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

filgrastim

+ carboplatin

+ cisplatin

BiologicalDrugProcedure
Who is being recruted

Urogenital Diseases+75

+ Genital Diseases

+ Adenocarcinoma

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 1994
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: August 26, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00002854
Principal SponsorCity of Hope Medical Center
Last updated: August 26, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdenocarcinomaAdnexal DiseasesAnus DiseasesBile Duct DiseasesBiliary Tract DiseasesBiliary Tract NeoplasmsBreast DiseasesCarcinomaColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsEsophageal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGallbladder DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersHead and Neck NeoplasmsIntestinal DiseasesIntestinal NeoplasmsKidney DiseasesKidney NeoplasmsLiver DiseasesLiver NeoplasmsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic Syndromes, HereditaryOvarian DiseasesOvarian NeoplasmsPancreatic DiseasesRectal DiseasesSkin DiseasesSkin NeoplasmsStomach DiseasesUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, Complex and MixedNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNevi and MelanomasNeuroendocrine TumorsGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Ovarian EpithelialAnus NeoplasmsBile Duct NeoplasmsBreast NeoplasmsColonic NeoplasmsEsophageal NeoplasmsGallbladder NeoplasmsCarcinoma, HepatocellularMelanomaNeoplasmsWilms TumorPancreatic NeoplasmsRectal NeoplasmsSarcomaOsteosarcomaStomach NeoplasmsNeuroectodermal Tumors, Primitive, Peripheral

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

City of Hope Comprehensive Cancer Center

Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps
CompletedOne Study Center