Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors

NCT00007813 | Completed Phase 1

• 4 other identifiers: JHOC-9512CDR0000064263NCI-V95-068894-12-23-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors.

Conditions

Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Testicular Germ Cell Tumor

Keywords

recurrent childhood rhabdomyosarcoma; childhood craniopharyngioma; recurrent childhood brain tumor; disseminated neuroblastoma; stage 4S neuroblastoma; recurrent neuroblastoma; stage IV childhood liver cancer; recurrent childhood liver cancer; childhood hepatoblastoma; childhood central nervous system germ cell tumor; stage III malignant testicular germ cell tumor; recurrent malignant testicular germ cell tumor; childhood germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; extragonadal germ cell tumor; childhood oligodendroglioma; childhood choroid plexus tumor; childhood grade III meningioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood medulloblastoma; recurrent childhood visual pathway and hypothalamic glioma; previously treated childhood rhabdomyosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent childhood ependymoma; childhood teratoma; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood extragonadal germ cell tumor; recurrent childhood malignant germ cell tumor; childhood atypical teratoid/rhabdoid tumor

Study Arms (1)

Arm 1

EXPERIMENTAL

Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

Arm 1

carboplatin DRUG

Arm 1

cyclophosphamide DRUG

Arm 1

etoposide DRUG

Arm 1

autologous bone marrow transplantation PROCEDURE

Arm 1

peripheral blood stem cell transplantation PROCEDURE

Arm 1

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven malignant solid tumor, including any of the following: * Rhabdomyosarcoma * Neuroblastoma * Ewing's sarcoma/primitive neuroectodermal tumor * Germ cell tumors * Childhood brain tumors * Hepatoblastoma * Metastatic disease OR has failed at least first-line therapy * Ineligible for higher priority protocols PATIENT CHARACTERISTICS: Age: * Under 36 at transplantation Performance status: * Karnofsky 60-100% Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 75,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * Liver function tests no greater than 2 times normal OR * No active hepatitis on liver biopsy * No hepatitis B infection Renal: * Creatinine no greater than 1.5 mg/dL OR * Glomerular filtration rate (preferably measured) greater than 60% of normal Cardiovascular: * Left ventricular ejection fraction at least 45% * No active congestive heart failure * No active arrhythmia Pulmonary: * Age 8 and under: clinically normal pulmonary function * Over age 8: FEV1 and FVC at least 50% predicted * Arterial blood gases normal and DLCO at least 50% if spirograms difficult to * interpret due to poor patient effort, recent surgery, or pulmonary tumor * involvement Other: * No mucositis or mucosal infection prior to myeloablative chemotherapy * HIV negative * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Amgen: collaborator
• Baxter Healthcare Corporation: collaborator
• Nexell Therapeutics Inc: collaborator

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (4)

• Leung W, Chen AR, Klann RC, et al.: Tumor cells frequently detected in marrow and mobilized blood hematopoietic grafts in neuroblastoma and primitive neuroblastoma and primitive neuroectodermal tumor: purging by immunomagnetic CD34+ cell selection. [Abstract] Blood 88: A-1917, 482a, 1996.

  BACKGROUND

• Chen AR, Cohen KJ, Eby LL, et al.: Heterogenous mobilization of CD34+ blood stem cells for autologous rescue of children with poor prognosis solid tumors. [Abstract] Blood 86: 403a, 1995.

  BACKGROUND

• Chen AR, Wiangon S, Noga SJ, et al.: Rapid engraftment of CD34+ selected peripheral blood stem cells (PBSC) after high-dose chemotherapy for patients with recurrent, refractory, or metastatic pediatric solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A2038, 530a, 1998.

  RESULT

• Leung W, Chen AR, Klann RC, Moss TJ, Davis JM, Noga SJ, Cohen KJ, Friedman AD, Small D, Schwartz CL, Borowitz MJ, Wharam MD, Paidas CN, Long CA, Karandish S, McMannis JD, Kastan MB, Civin CI. Frequent detection of tumor cells in hematopoietic grafts in neuroblastoma and Ewing's sarcoma. Bone Marrow Transplant. 1998 Nov;22(10):971-9. doi: 10.1038/sj.bmt.1701471.

  PMID: 9849694 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Liver Neoplasms; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Testicular Germ Cell Tumor; Hepatoblastoma; Testicular Neoplasms; Oligodendroglioma; Choroid Plexus Neoplasms; Astrocytoma; Medulloblastoma; Optic Nerve Glioma; Neuroectodermal Tumors, Primitive, Peripheral; Familial ependymoma; Teratoma; Ovarian Germ Cell Cancer; Rhabdoid Tumor

Interventions

Filgrastim; Carboplatin; Cyclophosphamide; Etoposide; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland 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; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

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; 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; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Allen R. Chen, MD, PhD, MHS

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  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: January 6, 2001
• First Posted: April 2, 2004
• Study Start: May 31, 1997
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)