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)

Syndrome

Recurrence

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Leukemia, Lymphoid

Neoplasm Metastasis

Anemia

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Prolymphocytic

Primary Myelofibrosis

Anemia, Refractory, with Excess of Blasts

Anemia, Refractory

Blast Crisis

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Myelodysplastic Syndrome With Excess Blasts

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Dermatologic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Cyclosporine

Cyclosporins

Lenograstim

Mycophenolic Acid

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.

All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10\^9/L for three consecutive days.

filgrastim

Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW \> 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.

cyclophosphamide

Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of \> 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.

cyclosporine

Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);

fludarabine phosphate

All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).

Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day.

mycophenolate mofetil

The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.

umbilical cord blood transplantation

The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).

total-body irradiation

Claudio G. Brunstein, MD, PhD

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

OBJECTIVES:

Primary

* Determine the 1-year survival of patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine, cyclophosphamide, and fractionated total-body irradiation.

Secondary

* Determine the incidence of transplant-related mortality at 6 months after UCBT.
* Evaluate the pattern of chimerism after double UCBT.
* Determine the incidence of neutrophil engraftment at day 42 after UCBT.
* Determine the incidence of platelet engraftment at 6 months after UCBT.
* Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT.
* Determine the incidence of chronic GVHD at 1 year after UCBT.
* Determine the disease-free survival at 1 and 2 years after UCBT.
* Determine the incidence of relapse at 1 year after UCBT.

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

* Preparative Regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients also undergo total-body irradiation twice daily on days -4 to -1.
* Umbilical Cord Blood Transplantation (UCBT): Patients undergo 1 or 2 units of UCBT on day 0. Patients receive filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours 2 or 3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2 or 3 times a day beginning on day -3 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen

Number of patients alive at 1 year after transplant.

Determine the incidence of transplant-related mortality at 6 months after UCBT

Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT.

Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC \> 5 x 10\^8/L of donor origin by day +42)

Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD.

Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.

Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)
Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases	NCT00309842	Acute Myeloid L... Acute Lymphocyt... Chronic Myeloge... Myelofibrosis MDS Refractory Anem... Chronic Lymphoc... Prolymphocytic ... Non-Hodgkin's L... Leukemia Lymphoma Multiple Myelom... Myelodysplastic...	filgrastim cyclophosphamid... cyclosporine fludarabine pho... mycophenolate m... umbilical cord ... total-body irra...	- 55 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for adult burkitt lymphoma