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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.

Overall Survival (OS)

Disease-free Survival (DFS)

Engraftment of Platelets

Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells

Engraftment of Neutrophils

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Central Nervous System Neoplasms

Nervous System Neoplasms

Cisplatin

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

peripheral blood stem cell transplantation

Darren Feldman, MD

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.

OBJECTIVES:

* Determine the safety of paclitaxel and ifosfamide followed by dose-escalated, dose-intensive paclitaxel, carboplatin, and ifosfamide with autologous peripheral blood stem cell support in patients with cisplatin-resistant germ cell tumor. (Phase I)
* Determine the maximum tolerated dose of paclitaxel, carboplatin, and ifosfamide when given with a high-dose treatment program in these patients. (Phase I)
* Determine the efficacy of this regimen when given as salvage therapy in the second-line or third-line setting, in terms of complete response, in these patients. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of paclitaxel, carboplatin, and ifosfamide followed by a phase II, open-label study.

* Phase I:

  * Paclitaxel, ifosfamide, and autologous peripheral blood stem cell (PBSC) collection: Patients receive paclitaxel IV over 3 hours on day 1 and ifosfamide IV over 2 hours on days 1-3. Patients undergo leukapheresis on days 11-13. Patients also receive filgrastim (G-CSF) subcutaneously (SC) twice daily beginning on day 3 and continuing until leukapheresis is completed. Beginning on day 14 or 21, patients may receive a second course of paclitaxel, ifosfamide, and G-CSF. Patients may also undergo additional leukapheresis.
  * Paclitaxel, carboplatin, ifosfamide, and autologous PBSC transplantation: Patients receive paclitaxel IV over 3 hours, high-dose carboplatin IV over 30 minutes, and ifosfamide IV over 4 hours on days 1-3. Patients also receive G-CSF SC beginning on day 3 and continuing until blood counts recover. Patients undergo reinfusion of autologous PBSCs on day 5. Treatment repeats every 21-28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel, carboplatin, and ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

* Phase II: Patients receive treatment as in phase I with paclitaxel, carboplatin, and ifosfamide at the MTD determined in phase I.

After completion of study treatment, patients are followed periodically for 1 year and then annually thereafter.

Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin

Phase I/II Trial of Sequential Paclitaxel/Ifosfamide Followed by Dose-Escalated, Dose-Intensive Carboplatin, Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients

Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)

Complete Response (CR): A complete response is defined as one of the following:

* Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).
* Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.
* Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

filgrastim

carboplatin

ifosfamide

paclitaxel

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors	NCT00432094	Childhood Germ ... Ovarian Cancer Teratoma	carboplatin etoposide ifosfamide paclitaxel thiotepa autologous hema... Mesna filgrastim	10 Years - 69 Years	Masonic Cancer Center, University of Minnesota
Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin	NCT00423852	Brain and Centr... Extragonadal Ge... Ovarian Cancer Teratoma Testicular Germ...	filgrastim carboplatin ifosfamide paclitaxel autologous hema... peripheral bloo...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for stage iii extragonadal seminoma