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Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissuePhase 1NCT00082784

Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms

A Phase 1 study testing Bortezomib, Alvocidib Hydrochloride and Pharmacological Study in people with Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Nodal Marginal Zone Lymphoma, run by National Cancer Institute (NCI) at 5 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

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomib, Alvocidib Hydrochloride and Pharmacological Study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
5 sitesUnited States
Study dates
Mar 2004to Sep 2014
Phase
Phase 1
Are there results?
None posted in the registry

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

  • WBC < 50,000/mm^3 for patients with circulating tumor cells
  • No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
  • No neuropathy >= grade 2
  • No other condition that would preclude study participation
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
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  • Prior autologous stem cell transplantation is allowed
  • No prior allogeneic stem cell transplantation
  • No other concurrent anticancer agents
  • No other concurrent investigational agents
  • Hemoglobin >= 8 g/dL
  • Platelet count >= 100,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Bilirubin =< 2 times upper limit of normal (ULN)
  • AST/ALT =< 3 times ULN
  • Creatinine =< 2 times ULN or Creatinine clearance >= 50 mL/min

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms.

SECONDARY OBJECTIVES:

  1. To determine the toxic effects and maximum tolerated dose of this regimen in these patients.

II. To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma.

IV. To determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Being tested
Bortezomib, Alvocidib Hydrochloride, Pharmacological Study
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Multiple Myeloma, Waldenstrom Macroglobulinemia

What participants receive

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

  • BortezomibDrug

    Given IV

  • Alvocidib HydrochlorideDrug

    Also called FLAVO, HL-275, HMR 1275

    Given IV

  • Pharmacological StudyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00082784
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bortezomib; Drug: Alvocidib Hydrochloride; Other: Pharmacological Study

What is being measured

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

  1. Recommended phase II dose

    Measured: 21 days

Secondary outcomes (5)

  1. Maximum tolerated dose, assessed according to NCI CTCAE v4.0

    Measured: 21 days

  2. Response

    Measured: Up to 8 years

  3. Response duration

    Measured: Up to 8 years

  4. Time to progression

    Measured: Up to 8 years

  5. Survival

    Measured: Up to 8 years

Timeline

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

  1. First posted19 May 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionOct 2012
  4. Study completionSep 2014

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082784
Sponsor's protocol ID
NCI-2009-00058
Other IDs
NCI-2009-00058, CDR0000360816, MCC 6413, MCC-6413, 6413, R21CA110953, P30CA076292, N01CM00100
Status last verified
Oct 2014
First submitted
14 May 2004
Last updated
23 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib, Alvocidib Hydrochloride and Pharmacological Study in people with Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Nodal Marginal Zone Lymphoma, run by National Cancer Institute (NCI) at 5 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 16 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Recommended phase II dose (time frame: 21 days). 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 NCT00082784.

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 23 Dec 2014.

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