Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endodermal Sinus Tumor

Teratoma

Testicular Neoplasms

Seminoma

Carcinoma, Embryonal

Choriocarcinoma

Dermoid Cyst

Dysgerminoma

Neoplasms, Germ Cell and Embryonal

Endocrine Gland Neoplasms

Urogenital Diseases

Urogenital Neoplasms

Genital Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms by Histologic Type

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Germ Cells Tumors

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Testicular Seminoma

Nonseminomatous Germ Cell Tumor

Embryonal Carcinoma

Testicular Yolk Sac Tumor

Extragonadal Germ Cell Tumor

Polyembryoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)

sunitinib malate

Dean F. Bajorin, MD

Robert J. Motzer, MD

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

OBJECTIVES:

Primary

* Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.

Secondary

* Determine the safety of this drug in these patients.
* Determine the time to tumor response and duration of tumor response in patients treated with this drug.

OUTLINE: This is a open-label study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 28 days and then periodically thereafter.

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors

National Cancer Institute (NCI)

Pfizer

Memorial Sloan Kettering Cancer Center

The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)

sunitinib malate

Sunitinib Malate

Age, Categorical

Sex: Female, Male

Dr. Robert Motzer

Stable Disease

Progression of Disease

Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Infections

Multiple Myeloma

Neoplasms, Plasma Cell

Breast Neoplasms

Syndrome

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Preleukemia

Myelodysplastic Syndromes

Burkitt Lymphoma

Neuroblastoma

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphoma, Non-Hodgkin

Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Breast Diseases

Skin Diseases

Hematologic Diseases

Disease Attributes

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Bone Marrow Diseases

Precancerous Conditions

Leukemia, B-Cell

Chronic Disease

Myeloproliferative Disorders

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Nerve Tissue

Lymphoma, B-Cell

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Germinoma

Trophoblastic Neoplasms

Adenocarcinoma

Pregnancy Complications, Neoplastic

Myelodysplastic-Myeloproliferative Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Acute Lymphoblastic Leukemia

Antibodies

Antibodies, Monoclonal

Ipilimumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

Immune Checkpoint Inhibitors

Patients receive ipilimumab IV over 90 minutes. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the MTD is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.

ipilimumab

therapeutic allogeneic lymphocytes

Ewa Carrier

This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PRIMARY OBJECTIVES:

I. To determine the dose of MDX-010 (ipilimumab) that can safely be administered to patients with persistent or progressive malignancy following allo-HCT.

II. To determine the pharmacokinetics of different doses of MDX-010 administered as a single dose to patients with persistent or progressive malignancy following allo-HCT.

III. By assessment of aims 1 and 2, to determine the best dosing regimen for further study of CTLA-4 blockade in conjunction with escalating dose donor-leukocyte infusions (DLI) in patients with evidence of residual or progressive malignancy following allo-HCT.

IV. To assess if there is preliminary evidence of efficacy following the administration of MDX-010 in this population.

OUTLINE:

Patients receive ipilimumab intravenously (IV) over 90 minutes.

Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.

Patients are followed at 4, 5, 6, 9, and 12 months and then annually thereafter.

Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

CTLA-4 Blockade With MDX-010 to Induce Graft-Versus-Malignancy Effects Following Allogeneic Hematopoietic Stem Cell Transplantation

Kaplan- Meier estimates of probability will be used.

Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Etoposide

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Ifosfamide

Lenograstim

Etoposide phosphate

Isophosphamide mustard

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.

filgrastim

carboplatin

etoposide

ifosfamide

paclitaxel

Given in two divided infusions on day -2 and day 0

autologous bone marrow transplantation

Two cycles of high dose chemotherapy followed by stem cell reinfusion

bone marrow ablation with stem cell support

Sumanta Pal, MD

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: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.

OBJECTIVES:

* Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer.
* Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.

Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.

Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm\^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.

Surgery may be performed after course 2 if indicated.

PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer

Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.

Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy

Estimated using the product-limit method of Kaplan and Meier.

City of Hope Medical Center

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.

HD Chemo and Auto Stem Cells

Age, Continuous

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment	NCT00453310	Extragonadal Ge... Ovarian Cancer Teratoma Testicular Germ...	sunitinib malat...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer	NCT00060372	Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Atypical Chroni... Childhood Myelo... Chronic Myeloge... Disseminated Ne... Malignant Neopl... Ovarian Chorioc... Ovarian Embryon... Ovarian Immatur... Ovarian Mature ... Ovarian Mixed G... Ovarian Monoder... Ovarian Polyemb... Ovarian Yolk Sa... Previously Trea... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Adult... Recurrent Grade... Recurrent Malig... Recurrent Mantl... Recurrent Neuro... Recurrent Ovari... Recurrent Ovari... Refractory Chro... Refractory Mult... Relapsing Chron... Stage I Multipl... Stage II Multip... Stage II Ovaria... Stage III Malig... Stage III Multi... Stage III Ovari... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast... Stage IV Ovaria... Testicular Chor... Testicular Chor... Testicular Chor... Testicular Chor... Testicular Chor... Testicular Embr... Testicular Embr... Testicular Embr... Testicular Embr... Testicular Embr... Testicular Embr... Testicular Tera... Testicular Yolk... Testicular Yolk... Testicular Yolk...	ipilimumab therapeutic all...	18 Years -	National Cancer Institute (NCI)
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer	NCT00002931	Brain and Centr... Extragonadal Ge... Ovarian Cancer Teratoma Testicular Germ...	filgrastim carboplatin etoposide ifosfamide paclitaxel autologous bone... bone marrow abl...	16 Years - 120 Years	City of Hope Medical Center
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors	NCT00470366	Brain and Centr... Extragonadal Ge... Ovarian Cancer Teratoma Testicular Germ...	pegfilgrastim cisplatin ifosfamide paclitaxel	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for ovarian immature teratoma