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Can a vitamin supplement make chemotherapy hit mesothelioma harder?

NCT ID NCT00541073

Disease control Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether adding vitamin B12 to standard chemotherapy helps people with pleural mesothelioma that cannot be removed by surgery. The trial gives participants pemetrexed and cisplatin, two chemotherapy drugs that block tumor cell growth in different ways, along with the vitamin supplement. The study also tracks how the body processes these drugs and whether certain gene variations affect response. About 60 adults with confirmed pleural mesothelioma take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pemetrexed combined with cisplatin and vitamin B12
What this could lead to
If it works, this could point toward a better-tolerated chemotherapy combination for people with inoperable pleural mesothelioma.
What could go wrong
This is a small phase 2 trial, so any benefit seen here would need confirmation in larger studies. Chemotherapy with pemetrexed and cisplatin can cause fatigue, nausea, and blood count changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2007

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed pleural mesothelioma * Unresectable disease Exclusion criteria: * Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status 0-2 * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance \> 45 mL/min * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Transaminases ≤ 3 times ULN (5 times ULN if liver metastases) * Not pregnant or nursing * Fertile patients of must use effective contraception during and for 6 months after completion of study treatment Exclusion criteria: * Hypersensitivity to pemetrexed disodium or any of its excipients * Peripheral neuropathy ≥ grade 2 * Impossible to receive study therapy due to geographical, social, familial, or psychological reasons PRIOR CONCURRENT THERAPY: Inclusion criteria: * At least 28 days since prior radiotherapy (21 days for injected radiotherapy) Exclusion criteria: * Prior chemotherapy * Prior yellow fever vaccine * Inability to discontinue aspirin (\> 1.3 g/day) or NSAIDs for 2 days prior to, during, and 2 days after day 1 of each course of study therapy * Concurrent participation in another clinical study

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Conditions

The condition(s) this trial relates to.

malignant mesothelioma malignant pleural mesothelioma Mesothelioma, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant mesothelioma

Contacts and locations

Locations

  • Centre Oscar Lambret

    Lille, 59020, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.