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A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, Myelodysplastic Syndromes, Neuroblastoma, Ovarian Cancer, Testicular Germ Cell Tumor

Thank you

Trial Information

A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease


OBJECTIVES:

Primary

- Determine the response rate in patients with refractory chronic graft-versus-host
disease treated with pentostatin.

Secondary

- Determine the time to next immunosuppressive agent (i.e., the time to progression from
best response) in patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Determine the infection rate in patients treated with this drug.

- Determine the pharmacokinetics of this drug in these patients.

- Determine the changes in lymphocyte populations in patients treated with this drug.

- Determine the survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete response after 6 courses receive 4 additional courses.
Patients who achieve a partial response, minor response, or stable disease after 6 courses
may receive up to 6 additional courses.

Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then
annually for 5 years.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed chronic graft-versus-host disease (GVHD) after allogeneic
hematopoietic stem cell transplantation or donor lymphocyte infusion

- Progressive, quiescent, or de novo onset

- Extensive stage disease requiring systemic immunosuppressive therapy, defined
according to Seattle criteria as 1 of the following:

- Generalized skin involvement

- Limited skin involvement or hepatic involvement with any of the following:

- Liver histology showing chronic progressive hepatitis, bridging necrosis,
or cirrhosis

- Eye involvement (i.e., Schirmer's test with less than 5 mm wetting)

- Involvement of minor salivary glands or oral mucosa

- Involvement of any other organ

- Failed prior corticosteroid therapy, meeting 1 of the following criteria:

- Progressive disease or less than a minor response in any organ system despite 2
weeks on steroid therapy at a dose of at least 1 mg/kg of methylprednisolone or
equivalent

- No response or minor response after at least 4 weeks of steroid therapy at a
dose of least 0.5 mg/kg of methylprednisolone or equivalent

- Less than a partial response after 8 weeks of steroid therapy at a dose of least
0.5 mg/kg of methylprednisolone or equivalent

- Required a dose of least 0.5 mg/kg of methylprednisolone or equivalent after
completion of at least 12 weeks of corticosteroid therapy in order to maintain a
partial response or better

- Required a dose of least 10 mg/kg of methylprednisolone or equivalent after
completion of at least 18 weeks of corticosteroid therapy in order to maintain a
partial response or better

- Progressive extensive stage chronic GVHD after completion of at least 18 weeks
of corticosteroid therapy and currently requiring reintroduction of
corticosteroid therapy at a dose of least 10 mg/kg of methylprednisolone or
equivalent OR an additional therapy (e.g., photopheresis or
psoralen-ultraviolet-light [PUVA] therapy)

- Established chronic GVHD either not improving or progressing on other
immunosuppressive agents allowed provided steroid refractoriness has been previously
established

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- 0-3

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 50,000/mm^3 (without transfusion)

Hepatic

- Not specified

Renal

- Creatinine clearance at least 30 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- Not specified

Endocrine therapy

- See Disease Characteristics

- No concurrent corticosteroids as antiemetics

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Concurrent continuation of other immunosuppressants administered during onset or
progression of chronic GVHD is allowed

- No concurrent mechanical ventilation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Response rate

Outcome Description:

Both complete and partial response will be assessed

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Sherif S. Farag, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University

Authority:

United States: Federal Government

Study ID:

CDR0000341678

NCT ID:

NCT00074035

Start Date:

December 2003

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • graft versus host disease
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • blastic phase chronic myelogenous leukemia
  • primary myelofibrosis
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • disseminated neuroblastoma
  • meningeal chronic myelogenous leukemia
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent neuroblastoma
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage II ovarian epithelial cancer
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III multiple myeloma
  • stage III ovarian epithelial cancer
  • stage III malignant testicular germ cell tumor
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV breast cancer
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV ovarian epithelial cancer
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Breast Neoplasms
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neuroblastoma
  • Ovarian Neoplasms
  • Trophoblastic Neoplasms
  • Lymphoma, Large-Cell, Immunoblastic
  • Neoplasms, Germ Cell and Embryonal
  • Gestational Trophoblastic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921