NCT00432094

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 10 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival. PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.

Detailed description

OBJECTIVES: Primary * Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens. Secondary * Determine disease-free survival (DFS) of patients treated with this regimen. * Determine the toxicity of tandem transplants * Determine the time to engraftment of neutrophils and platelets in patients treated for each transplant * Determine the number of patients unable to adequately mobilize sufficient peripheral blood stem cells (PBSC) for tandem transplantation. * Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem transplantation. * Compare OS and DFS of patients undergoing single vs tandem transplantation. OUTLINE: * Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell collection is complete. Patients undergo stem cell collection beginning on day 5 of G-CSF administration and continuing for at least 3 collections until the collection goal is met. * Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and continuing until stem cell collection is complete. Patients meeting the collection goal after PBSC mobilization via G-CSF alone or in combination with chemotherapy will undergo tandem autologous transplantation. If collection goal is not met but the patient has collected \> or = 2 x 10\^6 CD34 cells/kg, a single autologous transplant will be performed. * Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until blood counts recover. * Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later, patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days -6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

• Childhood Germ Cell Tumor
• Ovarian Cancer
• Teratoma

Interventions

Type	Name	Description
DRUG	carboplatin	Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes
DRUG	etoposide	600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
DRUG	ifosfamide	2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
DRUG	paclitaxel	225 mg/m\^2 intravenous over 3 hours on Day -7.
DRUG	thiotepa	150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
PROCEDURE	autologous hematopoietic stem cell transplantation	Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)
DRUG	Mesna	2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
BIOLOGICAL	filgrastim	Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

Timeline

• Start date: 2006-12-19
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2007-02-07
• Last updated: 2022-05-17
• Results posted: 2022-05-17

Locations

1 site across 1 country: United States