Completed

Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation

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What is being tested

aldesleukin

+ recombinant interferon alfa

+ sargramostim

Biological
Who is being recruted

Urogenital Diseases+114

+ Genital Diseases

+ Adnexal Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorCancer Treatment Centers of America
Last updated: March 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer. Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients. Determine the cellular response to this regimen in these patients. Assess progression free and overall survival rates in these patients. OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa. Beginning 14 days after the autologous stem cell transplant, patients receive daily subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous interleukin-2 on days 3-7, followed by 1 week of rest. Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest. Treatment is repeated for four courses. Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose escalation occurs in courses 2-4, in the absence of dose limiting toxicity. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

NCT00003408
Principal SponsorCancer Treatment Centers of America
Last updated: March 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesBlood Protein DisordersBone Marrow DiseasesBreast DiseasesCarcinomaCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsKidney DiseasesLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMesonephromaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic ProcessesNeoplastic Syndromes, HereditaryOvarian DiseasesParaproteinemiasPathologic ProcessesPregnancy ComplicationsPregnancy Complications, NeoplasticSkin DiseasesPathological Conditions, Signs and SymptomsTesticular DiseasesTrophoblastic NeoplasmsTumor Virus InfectionsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellLymphoma, T-CellSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, Complex and MixedNeoplasms, Connective and Soft TissueGerminomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesCarcinogenesisCarcinoma, Ovarian EpithelialBlast CrisisBreast NeoplasmsBurkitt LymphomaHodgkin DiseaseKidney NeoplasmsLeukemiaLeukemia, Hairy CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinMultiple MyelomaMycosis FungoidesMyelodysplastic SyndromesMyeloproliferative DisordersWilms TumorNeuroblastomaOvarian NeoplasmsRecurrenceSarcomaSezary SyndromeTeratomaTesticular NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousCarcinoma, EmbryonalSeminomaEndodermal Sinus TumorLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellGestational Trophoblastic DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellDendritic Cell Sarcoma, InterdigitatingPrimary Myelofibrosis

Criteria

DISEASE CHARACTERISTICS: Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR): Metastatic breast cancer Multiple myeloma Hodgkin's disease Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma Acute myelogenous leukemia beyond first remission Acute lymphoblastic leukemia beyond first remission Ovarian cancer Refractory malignancy and measurable or evaluable disease (at time of ASCR) Hormone receptor status: Not specified A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Midwestern Regional Medical Center

Zion, United StatesOpen Midwestern Regional Medical Center in Google Maps
CompletedOne Study Center