Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in

Status Completed

Clinical Trial Summary

RATIONALE: 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: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic cancer.

Clinical Trial Description

OBJECTIVES: I. Evaluate one year progression free survival, complete response rate, and overall survival in patients with metastatic small cell cancer treated with high dose paclitaxel, carboplatin, and topotecan with peripheral blood stem cell support. II. Assess the safety of this treatment regimen in this patient population.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour, followed by paclitaxel IV over 24 hours on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing through the day prior to the last collection day. Peripheral blood stem cells (PBSC) are collected over 3-5 days. Beginning approximately 21 days following mobilization, patients receive paclitaxel IV over 24 hours on day 1, immediately followed by carboplatin IV over 2 hours and topotecan IV over 24 hours on day 2, then G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover. PBSC are reinfused on day 5. Patients receive 1/3 of PBSC with each course. Treatment repeats every 4 weeks for 3 courses in the absence of unacceptable toxicity. Patients are followed at week 8 after treatment, then every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003943
Study type	Interventional
Source	Fox Chase Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	September 1998
Completion date	February 2003

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03918538` - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors	N/A
Recruiting	`NCT05078918` - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors	N/A
Active, not recruiting	`NCT04548830` - Safety of Lung Cryobiopsy in People With Cancer	Phase 2
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05583916` - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery	N/A
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting	`NCT06376253` - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers	Phase 1
Recruiting	`NCT05898594` - Lung Cancer Screening in High-risk Black Women	N/A
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT03575793` - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Terminated	`NCT01624090` - Mithramycin for Lung, Esophagus, and Other Chest Cancers	Phase 2
Terminated	`NCT03275688` - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting	`NCT04931420` - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	Phase 2
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Recruiting	`NCT06052449` - Assessing Social Determinants of Health to Increase Cancer Screening	N/A
Not yet recruiting	`NCT06017271` - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting	`NCT05787522` - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms