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2 Transplants: Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.

1 Transplants:Patients with Germ cell tumors who receive one transplant only.

Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes

carboplatin

600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.

etoposide

2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.

ifosfamide

225 mg/m\^2 intravenous over 3 hours on Day -7.

paclitaxel

150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4

thiotepa

Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)

autologous hematopoietic stem cell transplantation

Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

filgrastim

Najla El Jurdi, MD

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.

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.

This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants.

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

The number of patients who survive without any signs of symptions of that cancer or any other cancer.

Platelet engraftment is defined as 20,000/mm\^3 (20 x 10\^9/L) for 3 consecutive days unsupported by a platelet transfusion.

Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant.

Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.

Masonic Cancer Center, University of Minnesota

This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants. This trial is not a two arm protocol.

Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.

Adverse events are not separable by number of transplants because they were not recorded in to the University of Minnesota's CTMS system. Below you will see AEs for patients with 1 and 2 transplants pooled together.

2 Transplants/1 Transplant Arms (Overall)

Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Baseline Characteristics collected for the group as a whole prior to decision regarding number of transplants because if a patient did not have enough cells to do two transplants then they only received one transplants.

Dr. Najla El Jurdi

Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.

carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes

etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.

thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4

autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)

filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

2 Transplants

Patients with Germ cell tumors who receive one transplant only.

ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.

paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7.

autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)

Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.

filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

1 Transplant

The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Spots Global Cancer Trial Database for stage i extragonadal seminoma