Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

NCT00837200 | Terminated Phase 2 Results DMC

• 1 other identifier: 08-007
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory study to study the efficacy of combination regimen of Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma cell leukemia. Patients must have failed standard regimens for their cancers and could have had unlimited number of prior regimens. Patients will be staged appropriately for their disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each cycle and will have disease assessments every 2 cycles. Responding patients will continue therapy until disease progression or excessive toxicity. Responders who are candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell transplant after 4 cycles of ODD.

Conditions

Non-hodgkins Lymphoma; Hodgkins Lymphoma; Multiple Myeloma

Keywords

lymphoma; myeloma

Outcome Measures

Primary Outcomes (3)

• Tumor Response

  * Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU * Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles * MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion * Stable disease \> 2mo was a response

  16 weeks

• Study Specific Measure (Response)

  16 Weeks

• Study Specific Measure (Number of Participants Taken Off Study)

  16 weeks

Study Arms (1)

Oncaspar, Doxil, Decadron Regimen

EXPERIMENTAL

Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.

Drug: Oncaspar, Doxil, Decadron

Interventions

Oncaspar, Doxil, Decadron DRUG

Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.

Also known as: PEG-asparaginase, PEG-liposomal doxorubicin

Oncaspar, Doxil, Decadron Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented lymphoid malignancies, regardless of their origin (B,T or NK). These include ALL, CLL, HL, NHL, MM and PCL.
• Patients must have failed at least one standard regimen of chemotherapy for their illness. They may have had unlimited prior regimens.
• Performance status of ≤ 2 as per ECOG scale.
• ALT \< 2.5 times the upper limit of normal
• Anticipated life expectancy of at least 12 weeks
• Patients will be allowed to have baseline cytopenias, but ANC should be \>200/μl and a platelet count \> 25,000/ μl (within 2 weeks of starting therapy).
• Patients must have a serum creatinine level ≤ 2 mg/dL (within 2 weeks of starting therapy).
• Male or female adults of at least 18 years of age.
• Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations
• Left Ventricular Ejection Fraction (LVEF) \> 40% by echocardiogram or MUGA scan performed within 60 days prior to registration
• Women and men of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy.

You may not qualify if:

• Chemotherapy or radiotherapy received within the previous 2 weeks.
• Uncontrolled, active infection requiring IV antibiotics.
• Psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
• Pregnant or potential for pregnancy.
• Breast-feeding.
• Prior asparaginase therapy complicated by pancreatitis, allergic reaction, hemorrhagic event, or thrombosis
• Previous treatment with pegylated asparaginase
• Prior doxorubicin exposure, more than 400 mg/m2
• Clinically significant CHF
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three year interval.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17070, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma; Lymphoma; Neoplasms, Plasma Cell

Interventions

pegaspargase; liposomal doxorubicin; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Joseph J Drabick, MD
• Organization: Milton S Hershey Medical Center

jdrabick@hmc.psu.edu

717-531-5911

Study Officials

• Joseph J. Drabick, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2013
• Last Updated: July 24, 2017
• Results First Posted: August 20, 2014

Record last verified: 2017-06

Locations

US (1)