Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Sunitinib

Tyrosine Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate

Rena Buckstein

This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory diffuse or mediastinal large B-cell lymphoma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with relapsed or refractory, diffuse or mediastinal, large B-cell lymphoma treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the effects of this drug on peripheral blood biomarkers, circulating endothelial cells, and their precursors in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma

A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently

National Cancer Institute (NCI)

Arm I

Age, Continuous

Sex: Female, Male

Canada

Region of Enrollment

Two patients who were determined as ineligible were excluded from all analyses

Dr. Rena Buckstein

Objective Tumor Response

Overall Study

Infections

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Mastocytosis

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Monoclonal Gammopathy of Undetermined Significance

Burkitt Lymphoma

Thrombocytosis

Thrombocythemia, Essential

Precancerous Conditions

Waldenstrom Macroglobulinemia

Leukemia, Hairy Cell

Mastocytosis, Systemic

Castleman Disease

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphomatoid Granulomatosis

Hematologic Diseases

Bone Marrow Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Hairy Cell Leukemia

Systemic Mastocytosis

Unicentric Castleman Disease

Multicentric Castleman Disease

Lymphoma, Large-cell, Immunoblastic

tanespimycin

Antonio T. Fojo, MD, PhD

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis.

OBJECTIVES:

Primary

* Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels, in patients with systemic mastocytosis.

Secondary

* Determine the quality of life of patients treated with this drug.
* Determine hematological and non-hematological toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients achieving a partial response receive at least 4 additional courses beyond their maximum response. Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator.

Quality of life is assessed at baseline and before each treatment course.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 10-18 months.

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis

A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis

National Institutes of Health Clinical Center (CC)

Neoplasm Metastasis

Syndrome

Leukemia, Lymphoid

Hematologic Neoplasms

Anemia

Cytopenia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Preleukemia

Myelodysplastic Syndromes

Anemia, Refractory, with Excess of Blasts

Anemia, Refractory

Leukemia, Myeloid, Accelerated Phase

Blast Crisis

Leukemia, Neutrophilic, Chronic

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Myelodysplastic Syndrome With Excess Blasts

Chronic Neutrophilic Leukemia

Patients receiving umbilical cord blood transplantation.

The graft will be given by slow injection into each posterior iliac crest.

umbilical cord blood transplantation

John E. Wagner, MD

Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.

Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.

Objectives:

Primary

* Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection (IBMI) in patients with advanced or high-risk hematologic malignancy.
* Determine whether treatment with this regimen improves the time to neutrophil engraftment (compared to historical controls) in these patients.

Secondary

* Determine the incidence of sustained donor engraftment in patients treated with this regimen.
* Determine the relative contribution of each UCB unit to initial and sustained donor engraftment in these patients.
* Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease (GVHD) and chronic GVHD in patients treated with this regimen.
* Determine the incidence of day 100 and 180 transplant-related mortality in patients treated with this regimen.
* Determine the probability of survival at 100 days and 1 year post-transplantation in these patients.

Outline: This is a nonrandomized study.

Patients receive a myeloablative conditioning regimen. Patients also receive immunosuppression, growth factor, and supportive care as in protocol MT2005-10 (NCT00309842).

Patients receive 2 units of donor umbilical cord blood (UCB) by intra-bone marrow injection (IBMI) over 10 minutes each on day 0. If the IBMI procedure is not possible, then the UCB units are given intravenously (IV.)

After completion of study therapy, patients are followed periodically for 5 years.

Projected Accrual: A total of 36 patients will be accrued for this study.

Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)

Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.

Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.

Number of patients who received both cord blood units and achieved sustained donor engraftment

Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.

Number of patients who were deceased at days 100 and 180 from any cause other than relapse.

Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.

Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.

Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.

Masonic Cancer Center, University of Minnesota

Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.

Umbilical Cord Blood Transplant Patients

Age, Categorical

United States

This study was terminated early based on interim statistical analysis that indicated time to engraftment will not be improved compared to historical controls. While safe, lack of faster marrow recovery supports early discontinuation.

John E. Wagner, M.D.

Median Number of Days to Neutrophil Engraftment

Number of Patients Achieving Neutrophil Recovery

1 patient was not evaluable due to graft failure

Number of Patients With Evidence of Engraftment.

2 patients were not graded for acute GVHD due to graft failure.

Number of Patients With Acute Graft-versus-host Disease (GVHD)

Number of Patients With Transplant-related Mortality (TRM)

Number of Patients Surviving at Day 100 and 1 Year.

2 patients were not yet graded for acute gvhd

Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)

Only 7 patients were at risk for chronic GVHD

Number of Patients With Chronic Graft-versus-host Disease (GVHD).

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Disease Progression

Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.

Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.

Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer

This sample will be used for germline DNA analysis.

DNA analysis

RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.

RNA analysis

Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.

gene expression analysis

polymorphism analysis

biologic sample preservation procedure

Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.

flow cytometry

Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.

medical chart review

Lee Ratner, MD, PhD

RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

OBJECTIVES:

* To obtain high-quality, clinically annotated tissue from patients with human immunodeficiency virus (HIV)-1 malignancy.
* To study clinical, genetic, and immunologic parameters that have prognostic significance and/or are involved in the initiation and progression of HIV-1 malignancies, including complete genomic sequence determination of HIV-associated diffuse large B-cell lymphomas, lung cancer, anal cancer, and cervical cancer.

OUTLINE: This is a multicenter study.

Patients undergo tumor, lymph node, bone marrow, or skin biopsy, and peripheral blood mononuclear cells collection. Samples are submitted to the AIDS Malignancy Consortium (AMC) Biorepository and transferred to the AIDS and Cancer Specimen Resource (ACSR). Samples are then analyzed by the Genome Science Center of British Columbia (GSC-BC) and the HIV+ Tumor Molecular Characterization Project (HTMCP) for full genomic sequencing analysis that may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies by flow cytometry, cytogenetics, and molecular studies. Patients' clinical data, demographics, and treatment given are also collected prospectively in order to record treatment outcome and toxicity.

Patients are followed up at 6 months, 1 year, and 2 years for data-reporting purposes.

Fresh-frozen tissue, peripheral blood mononuclear cells, formalin-fixed, paraffin-embedded tissue

Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies

Summary of the specimens available by study arm

The Emmes Company, LLC

AIDS and Cancer Specimen Resource

University of Arkansas

AIDS Malignancy Consortium

As a laboratory study involving only sample collection through routine clinical care and data abstraction, no adverse events was collected for this study.

HIV-positive Diffuse Large B-cell Lymphoma Cases

HIV-positive Lung Cancer Cases

Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer.

HIV Positive Cervical Cancer Cases

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

HIV-positive persons age 18 and older with a diagnosis of a malignancy limited to the following diagnoses: any variant of diffuse large B cell lymphoma (DLBCL) except Burkitt's lymphoma, non-small cell lung malignancy or cervical cancer.

Madhu Mazumdar

Central pathology review

Collection of Tissue Specimen From Study Participants

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma	NCT00392496	Adult Diffuse L... Recurrent Adult... Stage IV Adult ...	sunitinib malat...	18 Years -	National Cancer Institute (NCI)
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis	NCT00132015	Chronic Myelopr... Leukemia Lymphoma Nonneoplastic C... Precancerous Co...	tanespimycin	18 Years -	National Institutes of Health Clinical Center (CC)
Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer	NCT00295880	Myeloproliferat... Leukemia Lymphoma Myelodysplastic...	umbilical cord ...	12 Years - 45 Years	Masonic Cancer Center, University of Minnesota
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies	NCT01567722	Lung Cancer Lymphoma	DNA analysis RNA analysis gene expression... polymorphism an... biologic sample... flow cytometry medical chart r...	18 Years -	AIDS Malignancy Consortium
Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma	NCT00392496	Adult Diffuse L... Recurrent Adult... Stage IV Adult ...	sunitinib malat...	18 Years -	National Cancer Institute (NCI)
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies	NCT01567722	Lung Cancer Lymphoma	DNA analysis RNA analysis gene expression... polymorphism an... biologic sample... flow cytometry medical chart r...	18 Years -	AIDS Malignancy Consortium

Spots Global Cancer Trial Database for adult diffuse large cell lymphoma