Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

All patients included in the study will treat with a salvage scheme according to each center.

After the end of salvage therapy, consolidation depends on the outcome of PET:

PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells.

Patients with negative PET after salvage therapy

All patients included in the study will treat with a salvage scheme according to each center.

After the end of salvage therapy, consolidation depends on the outcome of PET

PET positive, the consolidation therapy consists of 2 phases:

* phase1:common to all consists in a series of high-dose chemotherapy with Melphalan 200 mg/sqm, followed by reinfusion of autologous peripheral stem cells
* phase2:depends on the availability of a compatible donor. If there is a donor, the patient will continue with an allogeneic transplant preceded by a reduced intensity conditioning.

If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells.

Patients with positive PET after salvage therapy

Luca Castagna, MD

Armando Santoro, MD

PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.

This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.

Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory

Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory

Istituto Clinico Humanitas

Fondazione Italiana Linfomi - ETS

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endodermal Sinus Tumor

Teratoma

Germinoma

Seminoma

Choriocarcinoma

Neoplasms, Germ Cell and Embryonal

Trophoblastic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Germ Cells Tumors

Central Nervous System Germinoma

Testicular Seminoma

Nonseminomatous Germ Cell Tumor

Malignant Germ Cell Tumor

Testicular Yolk Sac Tumor

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Etoposide

Paclitaxel

Carboplatin

Dexamethasone

Albumin-Bound Paclitaxel

Cisplatin

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Diphenhydramine

Promethazine

Histamine H2 Antagonists

Isophosphamide mustard

Mesna

Lenograstim

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Adjuvants, Immunologic

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive treatment for 4 cycles administered every 21 days.

Cycles 1-4 (1 cycle = 21 days)

* paclitaxel 250 mg/m\^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
* ifosfamide 1500 mg/m\^2 IV daily on Days 2-5 with mesna protection as defined in the protocol
* cisplatin 25 mg/m\^2 IV daily on Days 2-5
* pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18

Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.

Patients will receive treatment for a total of 5 cycles.

Cycles 1-2 (1 cycle = 14 days)

* paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
* ifosfamide 2000 mg/m\^2 IV daily on Days 1-3 with mesna protection as defined in the protocol
* G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2)
* leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1

Cycles 3-5 (1 cycle = 21 days)

* carboplatin daily on Days 1-3
* etoposide 400 mg/m\^2 daily on Days 1-3
* stem cell reinfusion on day 5
* pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15

Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.

paclitaxel

ifosfamide

cisplatin

pegylated G-CSF

G-CSF

carboplatin

etoposide phosphate

stem cell reinfusion

Darren Feldman, MD

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below.

Primary Objective:

1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)

Secondary Objectives:

1. To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
2. To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
3. To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT
4. To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group).
5. To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.

Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment.

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

National Cancer Institute (NCI)

European Organisation for Research and Treatment of Cancer - EORTC

Movember Foundation

Institute of Cancer Research (ICR), United Kingdom

Cancer Research UK

UNICANCER

Irish Group CTI

Alliance for Clinical Trials in Oncology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Busulfan

Immunosuppressive Agents

G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion

Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously.

Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously.

Leukapheresis

Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2

Stem cell reinfusion

Jeffrey E Lancet, MD

During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.

1. Pre- Transplantation Phase -

   1. Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Alternatively, patients may receive G-CSF alone (same dose) as mobilization therapy.
   2. Leukapheresis will begin day 4 of G-CSF administration and proceed according to institutional guidelines. Leukapheresis will continue until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. A minimum recipient body weight is required to proceed to transplantation.
2. Transplantation Phase

   a. Conditioning/Preparative therapy - up to 30 days following PBSC collection, patients will begin conditioning therapy with Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2; subsequent doses will be adjusted based on pharmacokinetic monitoring.
   * Busulfan plasma level monitoring, collected around the first dose of busulfan b. Stem cell reinfusion - following 1 day of rest, previously collected autologous peripheral blood stem cells will be infused.
   * The administration of supportive measures (e.g. intravenous fluids, antihistamines) during stem cell reinfusion will be performed according to institutional guidelines.
3. Supportive care

   1. Antibiotic prophylaxis- according to hospital/institutional guidelines, and at the discretion of the treating physician.
   2. Growth factor support
   3. Transfusion support
   4. Prophylaxis for busulfan-induced seizures
4. During follow-up, patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant. The following medical procedures will be done:

   * Medical history and physical exam (including concurrent meds, vital signs, performance status and weight)
   * Standard labs
   * Bone marrow aspirate and biopsy

Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

A Pilot Study of Intravenous, Targeted-Dose Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk AML

100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease

Number of subjects who were able to collect at least 2 million CD34+ cells/kg

Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.

Number of participants alive and without disease relapse at 1 year posttransplant

Number of participants alive at 1 year posttransplant

ESP Pharma

H. Lee Moffitt Cancer Center and Research Institute

Autologous Hematopoietic Progenitor Cell Transplantation

Age, Continuous

Between 18 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Two patients enrolled and transplanted out of 24 targeted transplant accrual goal. Due to poor enrollment study closed and no further analyses were conducted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory	NCT00879528	Hodgkin's Lymph...	Patients with n... Patients with p...	18 Years -	Fondazione Italiana Linfomi - ETS
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors	NCT02375204	Germ Cell Tumor Teratoma Choriocarcinoma Germinoma Mixed Germ Cell... Yolk Sac Tumor Childhood Terat... Malignant Germ ... Extragonadal Se... Non-seminomatou... Seminoma	paclitaxel ifosfamide cisplatin pegylated G-CSF G-CSF carboplatin etoposide phosp... stem cell reinf...	14 Years -	Alliance for Clinical Trials in Oncology
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation	NCT00363467	Acute Myeloid L...	G-CSF Leukapheresis Busulfan Stem cell reinf...	56 Years - 74 Years	H. Lee Moffitt Cancer Center and Research Institute
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors	NCT02375204	Germ Cell Tumor Teratoma Choriocarcinoma Germinoma Mixed Germ Cell... Yolk Sac Tumor Childhood Terat... Malignant Germ ... Extragonadal Se... Non-seminomatou... Seminoma	paclitaxel ifosfamide cisplatin pegylated G-CSF G-CSF carboplatin etoposide phosp... stem cell reinf...	14 Years -	Alliance for Clinical Trials in Oncology
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors	NCT02375204	Germ Cell Tumor Teratoma Choriocarcinoma Germinoma Mixed Germ Cell... Yolk Sac Tumor Childhood Terat... Malignant Germ ... Extragonadal Se... Non-seminomatou... Seminoma	paclitaxel ifosfamide cisplatin pegylated G-CSF G-CSF carboplatin etoposide phosp... stem cell reinf...	14 Years -	Alliance for Clinical Trials in Oncology
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation	NCT00363467	Acute Myeloid L...	G-CSF Leukapheresis Busulfan Stem cell reinf...	56 Years - 74 Years	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for stem cell reinfusion