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

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00250718
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    Vincristine should be administered intravenously through a freely-running IV.
  • VP-16 — DRUG
    The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
  • 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
  • Dexamethasone — DRUG
    Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
  • Levofloxacin — DRUG
    Levofloxacin will be administered at 500 mg PO qd.

Study Details

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.

Key Dates

Start date
Oct 31, 2004
Status verified
Jul 2015
Primary completion
Nov 30, 2008
Completion
May 31, 2014

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Combination Treatment
    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

Primary Outcome Measure

Overall Response Rate (ORR), the Sum of Complete and Partial Responses [ Time Frame: Up to 6 months after first on-study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87131-

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By research site
University of New Mexico Cancer Center· Albuquerque, NM

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