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

NCT00002854 | Completed Phase 1 DMC

• 5 other identifiers: 94098P30CA033572CHNMC-IRB-94098NCI-V96-1042CDR0000065102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

stage IV colon cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IV gastric cancer; recurrent gastric cancer; localized osteosarcoma; metastatic osteosarcoma; stage IIIB breast cancer; recurrent pancreatic cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; stage IV anal cancer; recurrent anal cancer; stage IV esophageal cancer; recurrent esophageal cancer; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; recurrent Wilms tumor and other childhood kidney tumors; advanced adult primary liver cancer; recurrent adult primary liver cancer; recurrent osteosarcoma; recurrent gallbladder cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion

  30 days from start of course II of treatment

• Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion

  Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation

  30 days from start of course II of treatment

• Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion

  30 days from start of course II of treatment

Study Arms (1)

Sequential high dose chemotherapy

EXPERIMENTAL

Biological: filgrastim; Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: ifosfamide; Drug: mesna; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

Sequential high dose chemotherapy

carboplatin DRUG

Sequential high dose chemotherapy

cisplatin DRUG

Sequential high dose chemotherapy

cyclophosphamide DRUG

Sequential high dose chemotherapy

etoposide DRUG

Sequential high dose chemotherapy

ifosfamide DRUG

Sequential high dose chemotherapy

mesna DRUG

Sequential high dose chemotherapy

paclitaxel DRUG

Sequential high dose chemotherapy

peripheral blood stem cell transplantation PROCEDURE

Sequential high dose chemotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Breast Neoplasms; Stomach Neoplasms; Osteosarcoma; Pancreatic Neoplasms; Rectal Neoplasms; Anus Neoplasms; Esophageal Neoplasms; Sarcoma; Carcinoma, Ovarian Epithelial; Wilms Tumor; Carcinoma, Hepatocellular; Gallbladder Neoplasms; Bile Duct Neoplasms; Melanoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Filgrastim; Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Ifosfamide; Mesna; Paclitaxel; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stomach Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Rectal Diseases; Anus Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Neoplastic Syndromes, Hereditary; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Adenocarcinoma; Liver Neoplasms; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Bile Duct Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• George Somlo, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1994
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (1)