Non-Hodgkin's LymphomaPhase 2NCT00250718
Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
A Phase 2 study testing Vincristine, VP-16 and Rituximab in people with Non-Hodgkin's Lymphoma and Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Cancer
- What is being tested?
- Vincristine, VP-16 and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
About this study
Official title: Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach
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.
Read the detailed description
The purpose of the study is to see how effective the combination of chemotherapy drugs VP-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. Some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. This drug combination will be given to study participants in a low dose continuous basis. The study will also collect information about the side effects of the above drug combination on patients with these types of cancers. Previous studies on patients with non-Hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. The aim of this study is to test this drug combination in a controlled setting.
- Conditions
- Non-Hodgkin's Lymphoma, Cancer
- Being tested
- Vincristine, VP-16, Rituximab, Dexamethasone, Levofloxacin
- Keywords
- Non Hodgkin's Lymphoma, Phase II, Lymphoid malignancies
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
Also called Oncovin
Vincristine should be administered intravenously through a freely-running IV.
VP-16Drug
Also called Etoposide, NSC-67574, Vepesid, Ethylidene-Lignan P
The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
RituximabDrug
Also called Rituxan
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
DexamethasoneDrug
Also called decadron
Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
LevofloxacinDrug
Also called Levaquin, Levaquin Leva-Pak
Levofloxacin will be administered at 500 mg PO qd.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vincristine; Drug: VP-16; Drug: Rituximab; Drug: Dexamethasone; Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after first on-study treatment
Secondary outcomes (1)
Toxicity
Measured: End of 2 cycles (cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionNov 2008
- Study completionMay 2014
Why it stopped: Low rate of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dulcinea Quintana, MD, Principal investigator, UNM Cancer CenterRobert Hromas, MD, Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250718
- Sponsor's protocol ID
- INST 1003C
- Status last verified
- Jul 2015
- First submitted
- 4 Nov 2005
- Last updated
- 3 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach
- ClinicalTrials.gov ID
- NCT00250718
- Acronym / sponsor ID
- INST 1003C
- Conditions
- Non-Hodgkin's Lymphoma, Cancer
- Keywords
- Non Hodgkin's Lymphoma, Phase II, Lymphoid malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Posted 3 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to see how effective the combination of chemotherapy drugs VP-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. Some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. This drug combination will be given to study participants in a low dose continuous basis. The study will also collect information about the side effects of the above drug combination on patients with these types of cancers. Previous studies on patients with non-Hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. The aim of this study is to test this drug combination in a controlled setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Combination Treatment | Experimental | Drug: Vincristine, Drug: VP-16, Drug: Rituximab, Drug: Dexamethasone, Drug: LevofloxacinTreatment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VincristineAlso: OncovinVincristine should be administered intravenously through a freely-running IV. | Drug | Arm 1 Combination Treatment |
| VP-16Also: Etoposide, NSC-67574, Vepesid, Ethylidene-Lignan PThe VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. | Drug | Arm 1 Combination Treatment |
| RituximabAlso: RituxanThe 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 | Drug | Arm 1 Combination Treatment |
| DexamethasoneAlso: decadronDexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion. | Drug | Arm 1 Combination Treatment |
| LevofloxacinAlso: Levaquin, Levaquin Leva-PakLevofloxacin will be administered at 500 mg PO qd. | Drug | Arm 1 Combination Treatment |
Primary outcome
Overall Response Rate (ORR), the Sum of Complete and Partial Responses
Time frame: Up to 6 months after first on-study treatment
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.
1 secondary outcome
Toxicity
Time frame: End of 2 cycles (cycle = 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
- UNM Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dulcinea Quintana, MD principal investigator
UNM Cancer Center
Robert Hromas, MD study chair
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vincristine, VP-16 and Rituximab in people with Non-Hodgkin's Lymphoma and Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.