Neoplasms

Immune System Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Infections

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Mastocytosis

Leukemia

Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Lymphoma, Non-Hodgkin

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

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Diffuse Large B-Cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

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 Cancer Institute (NCI)

National Institutes of Health Clinical Center (CC)

Lymphoma, B-Cell

Leukemia, Lymphoid

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

B-cell Lymphoma

All Drugs and Chemicals

Vaccines

Heptavalent Pneumococcal Conjugate Vaccine

Immunologic Factors

Patients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4, 2, and 10. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.

Patients receive pneumococcal polyvalent vaccine as in arm A. Patients also receive autologous dendritic cell-tumor fusion vaccine (TL-DC) intradermally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.

dendritic cell vaccine therapy

cryotherapy

pneumococcal polyvalent vaccine

laboratory biomarker analysis

immunoenzyme technique

immunohistochemistry staining method

autologous dendritic cell-tumor fusion vaccine

Yi Lin, M.D.

RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.

PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site (Arm A). II. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro and delivered intradermally (ID) (Arm B). SECONDARY OBJECTIVES: I. For cryoablation candidates: To assess feasibility, overall response rate, clinical benefit rate, time to response, and duration of response (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess feasibility, clinical response rate, time to response, and duration of response (Arm B). TERTIARY OBJECTIVES: I. For cryoablation candidates: To assess the change over time in non-cryoablated nodes selected as the index lesions (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess the change over time in measurable nodes selected as the index lesions (Arm B). III. To monitor patients' immune response after vaccine therapy. IV. Assess the immune response to Prevnar in cancer patients. V. Assess the effect of DC vaccination on presence of myeloid suppressors. VI. Assess the effect of tumor antigen delivery methods (in vivo DC into cryoablated tumor vs. ID injection of in vitro generated DC + lysate) on T cell response. OUTLINE: Patients are assigned to 1 of 2 treatment arms. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for up to 2.5 years.

Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma

LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's Lymphoma"

Mayo Clinic

Neoplasm Metastasis

Syndrome

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

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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)
Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma	NCT01239875	Cutaneous B-cel... Extranodal Marg... Nodal Marginal ... Adult Diffuse M... Adult Diffuse S... Adult Grade III... Adult Immunobla... Adult Lymphobla... Grade 1 Follicu... Grade 2 Follicu... Grade 3 Follicu... Mantle Cell Lym... Marginal Zone L... Small Lymphocyt... Splenic Margina... Waldenstrom Mac...	dendritic cell ... cryotherapy pneumococcal po... laboratory biom... immunoenzyme te... immunohistochem... autologous dend...	18 Years - 90 Years	Mayo Clinic
Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma	NCT01239875	Cutaneous B-cel... Extranodal Marg... Nodal Marginal ... Adult Diffuse M... Adult Diffuse S... Adult Grade III... Adult Immunobla... Adult Lymphobla... Grade 1 Follicu... Grade 2 Follicu... Grade 3 Follicu... Mantle Cell Lym... Marginal Zone L... Small Lymphocyt... Splenic Margina... Waldenstrom Mac...	dendritic cell ... cryotherapy pneumococcal po... laboratory biom... immunoenzyme te... immunohistochem... autologous dend...	18 Years - 90 Years	Mayo Clinic
Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma	NCT01239875	Cutaneous B-cel... Extranodal Marg... Nodal Marginal ... Adult Diffuse M... Adult Diffuse S... Adult Grade III... Adult Immunobla... Adult Lymphobla... Grade 1 Follicu... Grade 2 Follicu... Grade 3 Follicu... Mantle Cell Lym... Marginal Zone L... Small Lymphocyt... Splenic Margina... Waldenstrom Mac...	dendritic cell ... cryotherapy pneumococcal po... laboratory biom... immunoenzyme te... immunohistochem... autologous dend...	18 Years - 90 Years	Mayo Clinic
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

Spots Global Cancer Trial Database for adult immunoblastic large cell lymphoma