Other Clinical Trial - Combination Chemotherapy With or Without Bortezomib

Status Completed

Clinical Trial Summary

This phase II trial studies how well combination chemotherapy with or without bortezomib works in treating patients with classical Hodgkin lymphoma that has come back or does not respond to prior treatment. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib is designed to block a protein that plays a role in cell function and growth. Bortezomib may cause cancer cells to die. It is not yet known if combination chemotherapy with or without bortezomib may work better in treating patients with classical Hodgkin lymphoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR), partial remissions (PR), and complete remissions (CR) after 3 cycles of bortezomib plus ifosfamide, carboplatin, and etoposide (ICE) (BICE) versus ICE in patients with relapsed/refractory classical Hodgkin lymphoma (cHL).

II. To evaluate 2-year progression-free survival (PFS) in patients treated with 3 cycles of BICE versus ICE.

SECONDARY OBJECTIVES:

I. To compare positron emission tomography (PET) scan response after 3 cycles of BICE versus ICE chemotherapy.

II. To compare serum levels of tumor necrosis factor (TNF) proteins (a proliferation-inducing ligand [APRIL], B lymphocyte stimulator [BLyS], soluble [s]CD30, and CD40L) and CC thymus and activation-related cytokine (TARC) at baseline and after 3 cycles of BICE versus ICE chemotherapy.

III. To correlate baseline cytokine/chemokine levels with response to therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive bortezomib intravenously (IV) over 5 seconds on days 1 and 4, ifosfamide IV continuously over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on days 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive ifosfamide, carboplatin and etoposide as in Arm A. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 2 years. ;

Study Design

Related Conditions & MeSH terms

Hodgkin Disease
Lymphoma
Recurrent Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma

Clinical Trial Details

NCT number	NCT00967369
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	August 24, 2009
Completion date	May 2, 2018

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05518318` - GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)	Phase 3
Recruiting	`NCT06190067` - Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma	Phase 2
Recruiting	`NCT02408861` - Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	Phase 1
Recruiting	`NCT05039073` - Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors	Phase 2
Suspended	`NCT01896999` - Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma	Phase 1/Phase 2
Active, not recruiting	`NCT04788043` - Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma	Phase 2
Active, not recruiting	`NCT04074746` - Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas	Phase 1/Phase 2
Active, not recruiting	`NCT03150329` - Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.	Phase 1
Recruiting	`NCT05162976` - CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed	Phase 1
Withdrawn	`NCT05711628` - A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Relapsed/Refractory Classical Hodgkin Lymphoma	Phase 3
Active, not recruiting	`NCT02595866` - Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms