Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach

NCT00250718 | Terminated Phase 2 Results DMC

• 1 other identifier: INST 1003C
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies. 1.2 To determine the toxicity profile of the above regimen in this patient population. 1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.

Conditions

Non-Hodgkin's Lymphoma; Cancer

Keywords

Non Hodgkin's Lymphoma; Phase II; Lymphoid malignancies

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR), the Sum of Complete and Partial Responses

  Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0). For CLL: complete remission (CR) requires the following for\>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count\<4,000/µL, 4) ANC\>1,500/µL, 5) platelets\>100,000/µL, 6) hemoglobin\>11 g/dL, 7) bone marrow lymphocytosis\<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for \>=2 months 1) decrease in previously enlarged nodes, spleen, and liver by \>=50%, 2) ANC\>=1,500/µL or platelets\>=100,000/µL, 3) hemoglobin\>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets. For MM, CR is no monoclonal protein (M-protein) in blood and urine and \<5% plasma cells in bone marrow on \>=2 determinations \>=6 wk apart \& stable bone disease \& calcium levels. PR is\>50% and \>90% decreases in serum \& urine M-protein, respectively, on \>=2 occasions for \>=6 wk, stable bone disease \& calcium.

  Up to 6 months after first on-study treatment

Secondary Outcomes (1)

• Toxicity

  End of 2 cycles (cycle = 28 days)

Study Arms (1)

Arm 1 Combination Treatment

EXPERIMENTAL

Treatment with combination therapy as follows: VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily At least 2 courses, but no more than 8 courses total, will be administered to each patient

Drug: Vincristine; Drug: VP-16; Drug: Rituximab; Drug: Dexamethasone; Drug: Levofloxacin

Interventions

Vincristine DRUG

Vincristine should be administered intravenously through a freely-running IV.

Also known as: Oncovin

Arm 1 Combination Treatment

VP-16 DRUG

The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.

Also known as: Etoposide, NSC-67574, Vepesid, Ethylidene-Lignan P

Arm 1 Combination Treatment

Rituximab DRUG

The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted. Patients will only receive rituximab if their tumors are CD20 positive CLL or NHL. Rituximab will only be administered to patients if they have previously had less than 8 doses. If a patient is treated with rituxan they should have at least 4 doses

Also known as: Rituxan

Arm 1 Combination Treatment

Dexamethasone DRUG

Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.

Also known as: decadron

Arm 1 Combination Treatment

Levofloxacin DRUG

Levofloxacin will be administered at 500 mg PO qd.

Also known as: Levaquin, Levaquin Leva-Pak

Arm 1 Combination Treatment

Eligibility Criteria

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

You may qualify if:

• All patients, 18 years of age or older, with Hodgkin's lymphoma, Non-Hodgkin lymphoma (NHL), multiple myeloma (MM), or chronic lymphocytic leukemia (CLL) are eligible.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must have a Zubrod performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,000 or cells/mm3 and platelet count \>50,000/mm3 and absence of a regular red blood cell or platelet transfusion requirement.
• Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 2.0 x upper limit of normal.
• Patients must have received at least two previous chemotherapy regimens for their disease.
• Patients must have measurable disease (NHL) or evaluable disease (MM, CLL).

You may not qualify if:

• Patients with symptomatic brain metastases are excluded from this study.
• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• New Mexico Cancer Care Alliance
• UNM Cancer Center

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Neoplasms

Interventions

Vincristine; Etoposide; Rituximab; Dexamethasone; Calcium Dobesilate; Levofloxacin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Results Point of Contact

• Title: Dulcinea Quintana, MD
• Organization: University of New Mexico

dcandelaria@salud.unm.edu

505-272-4661

Study Officials

• Dulcinea Quintana, MD

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert Hromas, MD

  University of Florida

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: October 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2014
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

US (1)