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Recurrent MelanomaPhase 2NCT00026221

Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

A Phase 2 study testing Recombinant Interferon Alfa and Bevacizumab in people with Recurrent Melanoma and Stage IV Skin Melanoma, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Skin Melanoma
What is being tested?
Recombinant Interferon Alfa and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesUnited States
Study dates
Nov 2001to Nov 2013
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

  • Histologically or cytologically confirmed cutaneous malignant melanoma
  • Must meet one of the following criteria:
  • Clinical evidence of metastatic disease
  • Unresectable regional lymphatic disease
  • Extensive in transit recurrent disease
  • Measurable disease
Show all 46Show fewer
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
  • No known brain metastases
  • No ocular melanoma
  • Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
  • Performance status - Karnofsky 60-100%
  • More than 6 months
  • White blood cells (WBC) at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No clinical evidence of coagulopathy
  • Bilirubin =< 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's disease provided patient is stable and asymptomatic)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal (ULN)
  • Prothrombin time (PT)/International normalized ratio (INR) less than 1.5
  • Creatinine =< 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • Protein < 1,000 mg on 24-hour urine collection for patients with proteinuria >= 1+
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of thrombosis (e.g., deep vein thrombosis), unless the following criteria are met:
  • INR in normal range (usually 2-3) AND on a stable dose of warfarin or low molecular weight heparin
  • No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., known varices or tumor involving major vessels)
  • No uncontrolled hypertension
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or interferon alfa
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • Human immunodeficiency virus (HIV) allowed provided otherwise well
  • At least 4 weeks since prior adjuvant interferon alfa
  • No prior interferon alfa for metastatic disease
  • No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2 [IL-2])
  • Prior IL-2 allowed for patients randomized to arm III only
  • No prior investigational antiangiogenic agents
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • At least 4 weeks since prior chemotherapy and recovered
  • At least 4 weeks since prior radiotherapy and recovered
  • No other concurrent investigational agents

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma

This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.

Read the detailed description

OBJECTIVES:

  1. Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Patients also receive low-dose interferon alpha (IFN-alpha) subcutaneously (SC) on days 1-14.

ARM II: Patients receive bevacizumab as in arm I.

ARM III: Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12. In all arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo restaging at the completion of course 12. Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year. Patients with stable disease after 1 year of treatment with bevacizumab and IFN-alpha (arms I and III) may continue to receive bevacizumab alone every 21 days (as in arm II) in the absence of disease progression.

Patients are followed every 3 months for 2 years.

Being tested
Recombinant Interferon Alfa, Bevacizumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Interferon AlfaBiological

    Also called IFN-A

    Given SC

  • BevacizumabBiological

    Also called Avastin, rhuMab-VEGF

    Given IV

Study groups in NCT00026221
Study groupRoleWhat they receive
Arm I (monoclonal antibody and biological therapy)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Receives: Biological: Recombinant Interferon Alfa; Biological: Bevacizumab
Arm II (monoclonal antibody)ExperimentalPatients receive bevacizumab as in arm I.
Receives: Biological: Bevacizumab
Arm III (monoclonal antibody and biological therapy)ExperimentalPatients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Receives: Biological: Recombinant Interferon Alfa; Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: Up to 2 years

  2. Progression-free Survival

    Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa

    Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.

    Measured: At baseline

  2. New Vessel Formation in Patient Tumor Samples

    Evaluated using immunohistochemistry.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00026221
Sponsor's protocol ID
NCI-2009-00006
Other IDs
NCI-2009-00006, CDR0000069010, 2001C0185, OSU-01H0185, 0132, NCI-2669, OSU 0132, 2669
Status last verified
Feb 2016
First submitted
9 Nov 2001
Last updated
17 Mar 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Interferon Alfa and Bevacizumab in people with Recurrent Melanoma and Stage IV Skin Melanoma, run by National Cancer Institute (NCI) at 2 sites 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 46 inclusion and 0 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: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 17 Mar 2016). 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?

Objective Response Rate (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00026221.

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 17 Mar 2016.

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